Hypertension and Kidney Function After Living Kidney Donation.

Importance: Recent guidelines call for better evidence on health outcomes after living kidney donation. Objective: To determine the risk of hypertension in normotensive adults who donated a kidney compared with nondonors of similar baseline health. Their rates of estimated glomerular filtration rate (eGFR) decline and risk of albuminuria were also compared. Design, Setting, and Participants: Prospective cohort study of 924 standard-criteria living kidney donors enrolled before surgery and a concurrent sample of 396 nondonors. Recruitment occurred from 2004 to 2014 from 17 transplant centers (12 in Canada and 5 in Australia); follow-up occurred until November 2021. Donors and nondonors had the same annual schedule of follow-up assessments. Inverse probability of treatment weighting on a propensity score was used to balance donors and nondonors on baseline characteristics. Exposure: Living kidney donation. Main Outcomes and Measures: Hypertension (systolic blood pressure [SBP] ≥140 mm Hg, diastolic blood pressure [DBP] ≥90 mm Hg, or antihypertensive medication), annualized change in eGFR (starting 12 months after donation/simulated donation date in nondonors), and albuminuria (albumin to creatinine ratio ≥3 mg/mmol [≥30 mg/g]). Results: Among the 924 donors, 66% were female; they had a mean age of 47 years and a mean eGFR of 100 mL/min/1.73 m2. Donors were more likely than nondonors to have a family history of kidney failure (464/922 [50%] vs 89/394 [23%], respectively). After statistical weighting, the sample of nondonors increased to 928 and baseline characteristics were similar between the 2 groups. During a median follow-up of 7.3 years (IQR, 6.0-9.0), in weighted analysis, hypertension occurred in 161 of 924 donors (17%) and 158 of 928 nondonors (17%) (weighted hazard ratio, 1.11 [95% CI, 0.75-1.66]). The longitudinal change in mean blood pressure was similar in donors and nondonors. After the initial drop in donors' eGFR after nephrectomy (mean, 32 mL/min/1.73 m2), donors had a 1.4-mL/min/1.73 m2 (95% CI, 1.2-1.5) per year lesser decline in eGFR than nondonors. However, more donors than nondonors had an eGFR between 30 and 60 mL/min/1.73 m2 at least once in follow-up (438/924 [47%] vs 49/928 [5%]). Albuminuria occurred in 132 of 905 donors (15%) and 95 of 904 nondonors (11%) (weighted hazard ratio, 1.46 [95% CI, 0.97-2.21]); the weighted between-group difference in the albumin to creatinine ratio was 1.02 (95% CI, 0.88-1.19). Conclusions and Relevance: In this cohort study of living kidney donors and nondonors with the same follow-up schedule, the risks of hypertension and albuminuria were not significantly different. After the initial drop in eGFR from nephrectomy, donors had a slower mean rate of eGFR decline than nondonors but were more likely to have an eGFR between 30 and 60 mL/min/1.73 m2 at least once in follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT00936078.

Association between diabetic status and risk of all-cause and cause-specific mortality on dialysis following first kidney allograft loss.

Background: Diabetes mellitus (DM) is associated with a greater risk of mortality in kidney transplant patients, primarily driven by a greater risk of cardiovascular disease (CVD)-related mortality. However, the associations between diabetes status at time of first allograft loss and mortality on dialysis remain unknown. Methods: All patients with failed first kidney allografts transplanted in Australia and New Zealand between 2000 and 2020 were included. The associations between diabetes status at first allograft loss, all-cause and cause-specific mortality were examined using competing risk analyses, separating patients with diabetes into those with pre-transplant DM or post-transplant diabetes mellitus (PTDM). Results: Of 3782 patients with a median (IQR) follow-up duration of 2.7 (1.1-5.4) years, 539 (14%) and 390 (10%) patients had pre-transplant DM or developed PTDM, respectively. In the follow-up period, 1336 (35%) patients died, with 424 (32%), 264 (20%) and 199 (15%) deaths attributed to CVD, dialysis withdrawal and infection, respectively. Compared to patients without DM, the adjusted subdistribution HRs (95% CI) for pre-transplant DM and PTDM for all-cause mortality on dialysis were 1.47 (1.17-1.84) and 1.47 (1.23-1.76), respectively; for CVD-related mortality were 0.81 (0.51-1.29) and 1.02 (0.70-1.47), respectively; for infection-related mortality were 1.84 (1.02-3.35) and 2.70 (1.73-4.20), respectively; and for dialysis withdrawal-related mortality were 1.71 (1.05-2.77) and 1.51 (1.02-2.22), respectively. Conclusions: Patients with diabetes at the time of kidney allograft loss have a significant survival disadvantage, with the excess mortality risk attributed to infection and dialysis withdrawal.

Arteriovenous Access for Hemodialysis: A Review.

Importance: Hemodialysis requires reliable vascular access to the patient's blood circulation, such as an arteriovenous access in the form of an autogenous arteriovenous fistula or nonautogenous arteriovenous graft. This Review addresses key issues associated with the construction and maintenance of hemodialysis arteriovenous access. Observations: All patients with kidney failure should have an individualized strategy (known as Patient Life-Plan, Access Needs, or PLAN) for kidney replacement therapy and dialysis access, including contingency plans for access failure. Patients should be referred for hemodialysis access when their estimated glomerular filtration rate progressively decreases to 15 to 20 mL/min, or when their peritoneal dialysis, kidney transplant, or current vascular access is failing. Patients with chronic kidney disease should limit or avoid vascular procedures that may complicate future arteriovenous access, such as antecubital venipuncture or peripheral insertion of central catheters. Autogenous arteriovenous fistulas require 3 to 6 months to mature, whereas standard arteriovenous grafts can be used 2 to 4 weeks after being established, and "early-cannulation" grafts can be used within 24 to 72 hours of creation. The prime pathologic lesion of flow-related complications of arteriovenous access is intimal hyperplasia within the arteriovenous access that can lead to stenosis, maturation failure (33%-62% at 6 months), or poor patency (60%-63% at 2 years) and suboptimal dialysis. Nonflow complications such as access-related hand ischemia ("steal syndrome"; 1%-8% of patients) and arteriovenous access infection require timely identification and treatment. An arteriovenous access at high risk of hemorrhaging is a surgical emergency. Conclusions and Relevance: The selection, creation, and maintenance of arteriovenous access for hemodialysis vascular access is critical for patients with kidney failure. Generalist clinicians play an important role in protecting current and future arteriovenous access; identifying arteriovenous access complications such as infection, steal syndrome, and high-output cardiac failure; and making timely referrals to facilitate arteriovenous access creation and treatment of arteriovenous access complications.

Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients (PISCES): protocol for a randomised controlled trial.

INTRODUCTION: Patients with kidney failure with replacement therapy (KFRT) suffer premature cardiovascular (CV) mortality and events with few proven pharmacological interventions. Omega-3 polyunsaturated essential fatty acids (n-3 PUFAs) are associated with a reduced risk of CV events and death in non-dialysis patients and in patients with established CV disease but n-3 PUFAs have not been evaluated in the high risk KFRT patient population. METHODS AND ANALYSIS: This multicentre randomised, placebo controlled, parallel pragmatic clinical trial tests the hypothesis that oral supplementation with n-3 PUFA, when added to usual care, leads to a reduction in the rate of serious CV events in haemodialysis patients when compared with usual care plus matching placebo. A target sample size of 1100 KFRT patients will be recruited from 26 dialysis units in Canada and Australia and randomised to n-3 PUFA or matched placebo in a 1:1 ratio with an expected intervention period of at least 3.5 years. The primary outcome to be analysed and compared between intervention groups is the rate of all, not just the first, serious CV events which include sudden and non-sudden cardiac death, fatal and non-fatal myocardial infarction, stroke, and peripheral vascular disease events. ETHICS AND DISSEMINATION: This study has been approved by all institutional ethics review boards involved in the study. Participants could only be enrolled following informed written consent. Results will be published in peer-reviewed journals and presented at scientific and clinical conferences. TRIAL REGISTRATION NUMBER: ISRCTN00691795.

Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis - a parallel arm, non-randomised feasibility pilot study protocol.

INTRODUCTION: Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis. METHODS AND ANALYSIS: This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings. PROTOCOL VERSION: 4 (16 November 2022). TRIAL REGISTRATION NUMBER: NCT05515991.

A Simple Exercise Program for Patients With End-Stage Kidney Disease to Improve Strength and Quality of Life: Clinical Research Protocol.

Background: Most patients with end-stage kidney disease (ESKD) appreciate the importance of exercise and would like to increase their physical activity; however, they report a few key barriers, including (1) lack of physician advice to do so, (2) lack of safe and convenient programs (ie, appropriate for home or neighborhood), and (3) cost. Importantly, patients indicated in a previous survey that they would prefer an exercise program that improves muscle strength and symptoms, and are less interested in cardiovascular disease prevention. Objective: To test the feasibility of a simple, prescribed exercise program using Nordic walking poles in patients with ESKD treated with dialysis. Design: Randomized multicenter pilot trial of an exercise intervention that includes Nordic walking poles, personalized physician exercise prescriptions, pedometers, and access to exercise videos, compared with standard of care, in patients being treated with maintenance dialysis. Setting: Multicenter tertiary care centers in Canada. Patients: Ambulatory adult patients with ESKD treated with peritoneal dialysis or hemodialysis (HD) for at least 6 months at participating sites are potentially eligible. Inclusion criteria include ability to use Nordic walking poles (either de novo or in place of mobility aid) and to provide informed consent in English or in French. Exclusion criteria include (1) any absolute contraindication to exercise, (2) baseline step count >8000 steps/day, (3) planned living donor kidney transplant, and (4) participation in another interventional trial that may affect the results of this study. Methods: This is a randomized multicenter pilot trial of an exercise intervention that consists of a prescription to exercise using Nordic walking poles, a pedometer to track activity, and access to exercise videos, with the comparator of standard of care (dialysis unit staff encouragement to exercise) in patients being treated with maintenance dialysis. Randomization is concealed and uses a 1:1 ratio for group assignment. Our specific aims are to determine the feasibility of patient recruitment, adherence to the exercise program (verified by step counts), and efficacy of the intervention on patient-important outcomes that were assessed as a priority by patients in a prior survey-specifically strength, fatigue, and sleep. We record days spent in hospital and loss of independent living to inform sample size calculations for a definitive trial of exercise in patient with ESKD treated with dialysis. Adverse events are closely monitored. Outcomes: Primary: Our recruitment goal is 90 to 150 patients over 27 months; adherence success will be defined if >75% of randomized patients, excluding those who are transplanted or deceased, achieve >80% of their prescribed steps at 6 and 12 months. Secondary Efficacy Outcomes: (1) strength-hand grip strength and 5 times sit to stand, (2) energy-Short Form (SF)-36 vitality subscale, and (3) sleep-Pittsburg Sleep Quality Index will be assessed at baseline, 6, and 12 months. Results: Trial recruitment started before the COVID-19 pandemic and the pandemic led to many interruptions and delays. Online exercise Web sites and a tailored video were added to the protocol to encourage activity when participants were unable or reluctant to walk in public places. Limitations: This trial was designed to include ambulatory patients with ESKD and does not address the burden of disease in patients with very restricted mobility. Trial Registration: NCT03787589.

Contexte: La plupart des patients atteints d'insuffisance rénale terminale (IRT) comprennent l'importance de l'exercice physique et souhaitent augmenter leur niveau d'activité. Ils signalent toutefois quelques obstacles, notamment 1) le manque de conseils médicaux pour le faire; 2) le manque de programmes sécuritaires et faciles (c.-à-d. pouvant être suivis à la maison ou dans le quartier); et 3) les coûts. Il convient de noter que les patients avaient indiqué dans une enquête précédente préférer un programme d'exercices améliorant la force musculaire et les symptômes liés à la maladie, et être moins intéressés par la prévention des maladies cardiovasculaires. Objectif: Dans une population de patients atteints d'IRT traités par dialyse, tester la faisabilité d'un programme prescrit et simple à suivre d'exercices impliquant l'utilisation de bâtons de marche nordique. Conception: Essai pilote randomisé multicentrique mené chez des patients traités par dialyse d'entretien. L'essai compare les soins habituels à une intervention comprenant des exercices avec bâtons de marche nordique, un programme personnalisé prescrit par un médecin, un podomètre et l'accès à des vidéos d'exercices. Cadre: Plusieurs centres de soins tertiaires au Canada. Sujets: Tous les patients adultes ambulatoires atteints d'IRT traités par dialyse péritonéale ou hémodialyse depuis au moins 6 mois dans les sites participants sont potentiellement admissibles. Pour être inclus, les patients doivent pouvoir utiliser des bâtons de marche nordique (de novo ou en remplacement de l'aide à la mobilité) et fournir un consentement éclairé en anglais ou en français. Les critères d'exclusion sont : 1) toute contre-indication absolue à l'exercice; 2) le fait de marcher déjà au moins 8 000 pas/jour; 3) avoir une transplantation rénale d'un donneur vivant prévue; 4) la participation à un autre essai interventionnel susceptible d'affecter les résultats de la présente étude. Méthodologie: Il s'agit d'un essai pilote randomisé multicentrique examinant une intervention en matière d'activité physique. L'intervention consiste en une prescription d'activité physique à l'aide de bâtons de marche nordique, elle donne accès à un podomètre pour suivre l'activité, ainsi qu'à des vidéos d'exercices; le comparateur est la norme de soins (encouragement par le personnel de l'unité de dialyse à pratiquer une activité physique) pour les patients traités par dialyse d'entretien. La randomisation est masquée et utilise un ratio de 1:1 pour l'affectation aux groupes. Nous examinons la faisabilité du recrutement des patients, l'observance du programme d'exercices (vérifiée par le nombre de pas) et l'efficacité de l'intervention sur les résultats de santé ayant été jugés comme importants et prioritaires par les patients dans une enquête précédente ­ plus précisément la force, la fatigue et le sommeil. Nous enregistrons le nombre de jours passés à l'hôpital et la perte de vie autonome afin d'éclairer les calculs de la taille de l'échantillon d'un essai définitif qui portera sur l'activité physique en contexte d'HD. Les événements indésirables sont étroitement surveillés. Mesures: Primaires : nous souhaitons recruter 90 à 150 patients sur une période de 27 mois; l'observance sera jugée comme un succès si plus de 75 % des patients randomisés (excluant les patients transplantés ou décédés) atteignent plus de 80 % de leur prescription de nombres de pas/jour après 6 et 12 mois. Paramètres secondaires d'efficacité : 1) Force ­ mesure de la force de préhension et 5 fois l'exercice de se lever d'une position assise; 2) Énergie ­ sous-échelle du test de vitalité SF-36; et 3) Sommeil ­ mesure de l'Indice de la qualité du sommeil Pittsburg à l'inclusion et après 6 mois et 12 mois. Résultats: Le recrutement s'est amorcé avant la pandémie de COVID-19, puis celle-ci a entraîné de nombreuses interruptions et retards. Des sites d'exercices en ligne et une vidéo personnalisée ont été ajoutés au protocole afin d'encourager les patients à continuer de faire de l'activité physique lorsqu'ils ne pouvaient pas marcher dans des lieux publics ou étaient réticents à le faire. Limites: Cet essai a été conçu pour inclure des patients ambulatoires atteints d'IRT, il ne traite pas du fardeau de la maladie chez les patients à mobilité très restreinte.

Psychosocial Distress in Patients With Advanced CKD by Racial Group and Immigrant Status: A Canadian Cross-sectional Study.

RATIONALE & OBJECTIVE: Patients with advanced chronic kidney disease (CKD) have been reported to experience profound psychosocial distress. Other work has established that patients with CKD from marginalized populations (including individuals who on the basis of race often face racism and related discrimination, termed "racialization") experience health care inequities. Given limited information on the intersection of these 2 phenomena, we assessed the association of psychosocial distress with racialized status and immigrant status in Canadians with advanced CKD. STUDY DESIGN: Secondary analysis of cross-sectional data. SETTING & PARTICIPANTS: 536 patients with advanced CKD (estimated glomerular filtration rate<30mL/min/1.73m2, with or without kidney replacement therapy) from multiple clinical centers in Toronto. EXPOSURE: Racialized status (individuals who identify as Asian or as African, Caribbean, or Black Canadian), immigrant status, and combined immigrant-racialized status. OUTCOME: Psychosocial distress, defined as the presence of depression, anxiety, or social difficulties (ie, a score of≥10 points on the Patient Health Questionnaire 9, Generalized Anxiety Disorder 7, or Social Distress 16 scales, respectively). ANALYTICAL APPROACH: The independent associations of racialized status and immigrant status with psychosocial distress, depression, anxiety, and social difficulties were examined using univariable- and multivariable-adjusted logistic regression. RESULTS: Mean age of the 536 participants was 57±16 (SD) years, 62% were male, and 45% were immigrants. Of the sample, 58% were White, 22% were African, Caribbean, or Black Canadian, and 20% were Asian. Psychosocial distress was present in 36% of participants (depression in 19%, anxiety in 12%, and social difficulties in 31%). To assess the combined impact of racialized and immigrant status, we created a variable with mutually exclusive categories: White nonimmigrant, racialized nonimmigrant, White immigrant, and racialized immigrant participants. In our final multivariable-adjusted model, compared with White nonimmigrant participants, racialized immigrant participants were more likely to have psychosocial distress (OR, 2.96 [95% CI, 1.81-4.81]), depression (OR, 1.87 [95% CI, 1.05-3.34]), and social difficulties (OR, 3.36 [95% CI, 2.03-5.57]). Overall similar associations were seen for racialized nonimmigrants and for White immigrants. LIMITATIONS: Convenience sample; small subgroups; combined exposure variable grouping Asian and African, Caribbean, and Black participants together; lack of data about mechanisms. CONCLUSIONS: Both racialized and immigrant status based on self-report of demographic characteristics were associated with psychosocial distress among patients with advanced CKD. These patients may benefit from culturally competent psychosocial support. PLAIN-LANGUAGE SUMMARY: Psychosocial distress is frequent in patients with advanced chronic kidney disease and impacts quality of life and clinical outcomes. Psychosocial distress may be especially scarring in people who are racialized (marginalized on account of their membership in a particular racial group) and/or who are immigrants. We assessed the association of psychosocial distress with racialized and immigrant status in Canadians with advanced chronic kidney disease. Among 536 participants from multiple medical centers in Toronto, we found that racialized and immigrant participants were more likely to have psychosocial distress, depression, and social difficulties compared with White nonimmigrant participants. This is likely related to the multiple intersectional challenges, including experience with racism and discrimination that racialized immigrant patients may face. Further studies are needed to elucidate the specific factors that contribute to more distress. The potential impact of culturally competent and safe support for these patients will also need to be studied.

Cardiac implications of upper-arm arteriovenous fistulas: A case series.

BACKGROUND: Cardiovascular disease is a major cause of morbidity and mortality in patients with end-stage kidney disease. Arterio-venous fistulas (AVF), the gold standard for hemodialysis vascular access, are known to alter cardiac morphology and circulatory hemodynamics. We present a prospective case series of patients after creation of an AVF, explore the timeline for changes in their cardiac morphology, and detail considerations for clinicians. METHODS: Patients were recruited in 2010 at multiple centers immediately prior to the creation of an upper-arm AVF and the initiation of hemodialysis. Cardiovascular magnetic resonance images were taken at intake before the creation of the AVF, 6-month follow-up, and 12-month follow-up. Image segmentation was used to measure left ventricular volume and mass, left atrial volume, and ejection fraction. RESULTS: Eight patients met eligibility criteria. All eight patients had a net increase in left ventricular mass over enrollment, with a mean increase of 9.16 g (+2.96 to +42.66 g). Five participants had a net decrease in ejection fraction, with a mean change in ejection fraction of -5.4% (-21% to +5%). Upon visual inspection the patients with the largest ejection fraction decrease had noticeably hypertrophic and dilated ventricles. Left atrial volume change was varied, decreasing in five participants, while increasing in three participants. Changes in morphology were present at 6-month follow-up, even in patients who did not maintain AVF patency for the entirety of the 6-month period. CONCLUSION: All patients included in this prospective case series had increases in left ventricular mass, with variability in the effects on the ejection fraction and left atrial volume. As left ventricular mass is an independent predictor of morbidity and mortality, further research to determine appropriate vascular access management in both end-stage kidney disease and kidney transplant populations is warranted.

Infectious outcomes of fibrin sheath disruption in tunneled dialysis catheters.

BACKGROUND AND OBJECTIVES: Fibrin sheath (FS) formation around tunneled central venous catheters (CVC) increases the risk of catheter-related bloodstream infections due to bacterial adherence to a biofilm. We sought to investigate whether FS disruption (FSD) at the time of CVC removal or exchange affects infectious outcomes in patients with CVC-related infections. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Retrospective cohort study of 307 adult maintenance hemodialysis patients aged 18 years or older at a single center academic-based hemodialysis program (UHN, Toronto) who developed CVC-related infections requiring CVC removal or exchange between January 2000 and January 2019. Exposure was FSD at the time of CVC removal or exchange. Outcomes were infectious metastatic complications, recurrent infection with the same organism within 1 year, or death due to infection. We created a Markov Multi-State Model (MMSM) to assess patients' trajectories through time as they transitioned between states. A time-to-event analysis was performed, adjusted for clinically relevant factors. RESULTS: There was no significant relationship between FSD status at the time of CVC removal, the development of infectious complications in the multivariable model (adjusted HR = 0.71, 95% CI 0.09-5.80, p = 0.76), or mortality from infection (HR = 0.84, 95% CI 0.34-2.11, p = 0.73). CONCLUSIONS: FSD at the time of CVC removal was not associated with increased risk of infectious complications or death due to infection. Further prospective study is needed to determine whether FSD contributes to reducing CVC infectious related complications.

Sex Disparity in Cause-Specific and All-Cause Mortality Among Incident Dialysis Patients.

RATIONALE & OBJECTIVE: Early mortality rates of female patients receiving dialysis have been, at times, observed to be higher than rates among male patients. The differences in cause-specific mortality between male and female incident dialysis patients with kidney failure are not well understood and were the focus of this study. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Incident patients who had initiated dialysis in Australia and New Zealand in 1998-2018. EXPOSURE: Sex. OUTCOMES: Cause-specific and all-cause mortality while receiving dialysis, censored for kidney transplant. ANALYTICAL APPROACH: Adjusted cause-specific proportional hazards models, focusing on the first 5 years following initiation of dialysis. RESULTS: Among 53,414 patients (20,876 [39%] female) followed for a median period of 2.8 (IQR, 1.3-5.2) years, 27,137 (51%) died, with the predominant cause of death attributed to cardiovascular disease (18%), followed by dialysis withdrawal (16%). Compared with male patients, female patients were more likely to die in the first 5 years after dialysis initiation (adjusted hazard ratio [AHR], 1.08 [95% CI, 1.05-1.11]). Even though female patients experienced a lower risk of cardiovascular disease-related mortality (AHR, 0.93 [95% CI, 0.89-0.98]) than male patients, they experienced a greater risk of infection-related (AHR, 1.20 [95% CI, 1.10-1.32]) and dialysis withdrawal-related (AHR, 1.19 [95% CI, 1.13-1.26]) mortality. LIMITATIONS: Possibility of residual and unmeasured confounders. CONCLUSIONS: Compared with male patients, female patients had a higher risk of all-cause mortality in the first 5 years after dialysis initiation, a difference driven by higher rates of mortality from infections and dialysis withdrawals. These findings may inform the study of sex differences in mortality in other geographic settings.

Hemodialysis Arteriovenous Access Cosmesis Scale (AVACS): A new measure for vascular access.

RATIONALE AND OBJECTIVE: This study aimed to develop a cosmesis scale to evaluate the cosmetic appearance of hemodialysis (HD) arteriovenous (AV) accesses from the perspective of the patient and clinician, which could be incorporated into clinical trials. STUDY DESIGN: Using a modified Delphi process, two AV access cosmesis scale (AVACS) components were developed in a four-round Delphi panel consisting of two surveys and two consensus meetings with two rounds of patient consultation. SETTING AND PARTICIPANTS: The Delphi panel consisted of 15 voting members including five interventional or general nephrologists, five vascular surgeons, three interventional radiologists, and two vascular access nurse coordinators. Four patients experienced with vascular access were involved in patient question development. ANALYTICAL APPROACH: For a component to be included in the AVACS, it had to meet the prespecified panel consensus agreement of ⩾70%. RESULTS: The clinician component of the AVACS includes nine questions on the following AV access features: scarring, skin discoloration, aneurysm/pseudoaneurysms and megafistula appearance. The patient component includes six questions about future vascular access decisions, interference with work or leisure activities, clothing choices, self-consciousness or attractiveness, emotional impact, and overall appearance. LIMITATIONS: Delphi panel methods are subjective by design, but with expert clinical opinion are used to develop classification systems and outcome measures. The developed scale requires further validation testing but is available for clinical trial use. CONCLUSIONS: While safety and efficacy are the primary concerns when evaluating AV access for HD, cosmesis is an important component of the ESKD patient experience. The AVACS has been designed to assess this important domain; it can be used to facilitate patient care and education about vascular access choice and maintenance. AVACS can also be used to inform future research on developing new techniques for AV access creation and maintenance, particularly as relates to AV access cosmesis.

Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice.

BACKGROUND: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative. METHODS: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors. DISCUSSION: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.

The Living Kidney Donor Safety Study: Protocol of a Prospective Cohort Study.

Background: Living kidney donation is considered generally safe in healthy individuals; however, there is a need to better understand the long-term effects of donation on blood pressure and kidney function. Objectives: To determine the risk of hypertension in healthy, normotensive adults who donate a kidney compared with healthy, normotensive non-donors with similar indicators of baseline health. We will also compare the 2 groups on the rate of decline in kidney function, the risk of albuminuria, and changes in health-related quality of life. Design Participants and Setting: Prospective cohort study of 1042 living kidney donors recruited before surgery from 17 transplant centers (12 in Canada and 5 in Australia) between 2004 and 2014. Non-donor participants (n = 396) included relatives or friends of the donor, or donor candidates who were ineligible to donate due to blood group or cross-match incompatibility. Follow-up will continue until 2021, and the main analysis will be performed in 2022. The anticipated median (25th, 75th percentile, maximum) follow-up time after donation is 7 years (6, 8, 15). Measurements: Donors and non-donors completed the same schedule of measurements at baseline and follow-up (non-donors were assigned a simulated nephrectomy date). Annual measurements were obtained for blood pressure, estimated glomerular filtration rate (eGFR), albuminuria, patient-reported health-related quality of life, and general health. Outcomes: Incident hypertension (a systolic/diastolic blood pressure ≥ 140/90 mm Hg or receipt of anti-hypertensive medication) will be adjudicated by a physician blinded to the participant's donation status. We will assess the rate of change in eGFR starting from 12 months after the nephrectomy date and the proportion who develop an albumin-to-creatinine ratio ≥3 mg/mmol (≥30 mg/g) in follow-up. Health-related quality of life will be assessed using the 36-item RAND health survey and the Beck Anxiety and Depression inventories. Limitations: Donation-attributable hypertension may not manifest until decades after donation. Conclusion: This prospective cohort study will estimate the attributable risk of hypertension and other health outcomes after living kidney donation.

Contexte: Chez les personnes en bonne santé, faire don d'un rein est généralement considéré comme sûr. Il convient toutefois de mieux comprendre les effets à long terme de ce don sur la pression artérielle et la fonction rénale. Objectifs: Déterminer le risque d'hypertension chez les adultes sains et normotendus qui donnent un rein par rapport à des non-donneurs sains et normotendus ayant des indicateurs de santé de base similaires. Nous comparerons également le taux de réduction de la fonction rénale, le risque d'albuminurie et les changements dans la qualité de vie liée à la santé entre les deux groupes. Cadre type d'étude et participants: Étude de cohorte rétrospective menée sur 1 042 donneurs de rein vivants, recrutés avant la chirurgie dans 17 centres de transplantation (12 au Canada et 5 en Australie) entre 2004 et 2014. Le groupe des non-donneurs (n=396) était constitué de parents ou amis du donneur, ou de candidats donneurs non admissibles à faire un don en raison d'une incompatibilité de groupe sanguin ou lors du test de compatibilité croisée. Le suivi s'est poursuivi jusqu'en 2021 et l'analyse principale sera effectuée en 2022. Le temps de suivi médian prévu (25e percentile, 75e percentile, maximum) après le don est de 7 ans (6, 8, 15 ans). Mesures: Les donneurs et les non-donneurs ont complété le même calendrier de mesures à l'inclusion et pendant le suivi (une date simulée de néphrectomie a été attribuée aux non-donneurs). Des mesures annuelles de pression artérielle, de débit de filtration glomérulaire estimé (DFGe), d'albuminurie, de qualité de vie liée à la santé autodéclarée et de santé générale ont été obtenues. Issues principales: L'hypertension incidente (pression artérielle systolique/diastolique ≥ 140/90 mm Hg ou prise d'un médicament antihypertenseur) sera jugée par un médecin aveugle au statut de don du participant. Nous évaluerons le taux de variation du DFGe à partir de 12 mois après la date de la néphrectomie et la proportion de participants qui développeront un rapport albumine/créatinine ≥ 3 mg/mmol (≥ 30 mg/g) pendant le suivi. La qualité de vie liée à la santé sera évaluée à l'aide du questionnaire de santé RAND de 36 questions et de l'Inventaire d'anxiété et de dépression de Beck. Limites: L'hypertension attribuable au don pourrait ne pas se manifester avant des décennies après le don. Conclusion: Cette étude de cohorte prospective permettra d'estimer le risque d'hypertension attribuable au don et d'autres effets sur la santé du donneur après un don de rein.

KDOQI 2019 Vascular Access Guidelines: What Is New.

The new Kidney Disease Outcomes Quality Initiative (KDOQI) Vascular Access Guidelines have a patient focus for comprehensive vascular access management. The patient's unique circumstances and individualized needs are the foundation of their dialysis access strategy, which is interlinked with the patient's End Stage Kidney Disease (ESKD) Life-Plan. The ESKD Life-Plan is an individualized and comprehensive map for dialysis modalities and vascular access for the lifetime of the patient. New targets are introduced that align with this patient-centered approach. They are less detail prescriptive than prior vascular access guidelines, giving opportunity for vascular access management at the clinician's discretion, partly in consideration of constraints of local resources and available expertise; however, the guidelines also emphasize the importance of high-quality standards with defined targets for achieving the guideline's overarching goal for vascular access care. The guidelines made significant changes relevant to the interventionalist, including selective use of vessel mapping in planning for vascular access, choice of vascular access that allows for considering endovascular access creations, and endovascular treatment (e.g., angioplasty, stent graft insertions) based on clinical indicators found on routine clinical monitoring. To that end, preemptive angioplasty of fistulas and grafts with stenosis, not associated with clinical indicators, is not recommended. New content in these guidelines also includes the use of stent grafts and management of central venous stenosis. The new KDOQI Vascular Access Guidelines 2019 represent a rigorous review of the evidence; however, the available evidence to guide vascular access practice remains limited. There is a significant need and opportunity for new and ongoing high-quality research to inform best practice.

Patterns of Antimicrobial Use in an Outpatient Hemodialysis Unit.

BACKGROUND: Patients receiving hemodialysis (HD) are at high risk of infections, including those caused by multidrug-resistant organisms. Given that antimicrobial exposure is a major risk factor for the emergence of these resistant organisms, minimizing inappropriate use is imperative. To optimize use, it is important to understand patterns of antimicrobial prescribing in this setting. OBJECTIVES: To measure antimicrobial use and to describe prescribing patterns among patients receiving outpatient HD. METHODS: A retrospective observational case series study was performed in an outpatient HD unit from February to April 2017. Adults for whom at least 1 antimicrobial was prescribed were included. The primary outcome was total antimicrobial days of therapy (DOT) per 1000 patient-days. Secondary outcomes were the characteristics of the antimicrobial prescriptions, in terms of antimicrobial class, indication, purpose, route, and prescriber group. RESULTS: Antimicrobials were prescribed for 53 (16%) of the 330 patients treated in the HD unit during the study period; the total number of prescriptions was 75. Antimicrobial use was 27.5 DOTs/1000 patient-days. Fluoroquinolones were the most frequently prescribed type of antimicrobial (n = 17, 23%), whereas the second most frequently prescribed were first-generation cephalosporins (n = 16, 21%). The most common indication was skin or soft-tissue infection (n = 14, 19%), followed by bloodstream infection (n = 13, 17%). Of the 75 antimicrobials, 48 (64%) were prescribed for empiric therapy, 19 (25%) for targeted therapy, and 8 (11%) for prophylaxis. Two-thirds of the antimicrobials prescribed (n = 50, 67%) were oral medications, and most (n = 72, 96%) were ordered by hospital prescribers. CONCLUSIONS: Antimicrobial use was common in this study setting, with 1 in 6 HD patients receiving this type of medication. The findings of this study create opportunities to standardize antimicrobial prescribing at the local level for common infections that occur in patients receiving outpatient HD.

CONTEXTE: Les patients sous hémodialyse (HD) présentent un risque élevé d'infections, y compris celles provoquées par des organismes multirésistants. Étant donné que l'exposition aux antimicrobiens est un facteur de risque majeur pour l'émergence de ces organismes résistants, il est impératif de minimiser l'utilisation inappropriée. Pour optimiser l'utilisation, il importe de comprendre les tendances de prescription d'antimicrobiens dans ce contexte. OBJECTIFS: Mesurer l'utilisation des antimicrobiens et décrire les schémas de prescription chez les patients recevant une HD ambulatoire. MÉTHODES: Une étude rétrospective de séries de cas a été réalisée dans une unité d'hémodialyse pour patients externes de février à avril 2017. Les adultes à qui au moins 1 antimicrobien avait été prescrit ont été inclus dans l'étude. Le paramètre d'évaluation principal était le nombre total de jours de traitement antimicrobien (JTA) pour 1000 jours-patients. Les paramètres secondaires étaient les caractéristiques des prescriptions d'antimicrobiens, en termes de classe d'antimicrobiens, d'indication, d'objectif, de voie d'administration et de groupe de prescripteurs. RÉSULTATS: Des antimicrobiens ont été prescrits à 53 (16 %) des 330 patients traités dans l'unité d'HD au cours de la période d'étude, pour un nombre total de prescriptions de 75. L'utilisation d'antimicrobiens était de 27,5 JTA/1000 jours-patients. Les fluoroquinolones étaient le type d'antimicrobien le plus fréquemment prescrit (n = 17, 23 %) et les céphalosporines de première génération (n = 16, 21 %) étaient le deuxième type. Une infection de la peau ou des tissus mous (n = 14, 19 %) était l'indication la plus courante, suivie d'une infection du sang (n = 13, 17 %). Sur les 75 antimicrobiens, 48 (64 %) ont été prescrits pour un traitement empirique, 19 (25 %) pour un traitement ciblé et 8 (11 %) pour une prophylaxie. Les deux tiers des antimicrobiens prescrits (n = 50, 67 %) étaient des médicaments oraux, et la plupart (n = 72, 96 %) ont été prescrits par des prescripteurs hospitaliers. CONCLUSIONS: L'utilisation d'antimicrobiens était courante dans le cadre de cette étude, où 1 patient sous HD sur 6 recevait ce type de médicament. Les résultats de cette étude créent des opportunités de normaliser la prescription d'antimicrobiens au niveau local pour les infections courantes qui surviennent chez les patients recevant une HD ambulatoire.

Factors Associated With Advanced Colorectal Neoplasia in Patients With CKD.

RATIONALE & OBJECTIVE: The risk of developing colorectal cancer in patients with chronic kidney disease (CKD) is twice that of the general population, but the factors associated with colorectal cancer are poorly understood. The aim of this study was to identify factors associated with advanced colorectal neoplasia in patients with CKD. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: Patients with CKD stages 3-5, including those treated with maintenance dialysis or transplantation across 11 sites in Australia, New Zealand, Canada, and Spain, were screened for colorectal neoplasia using a fecal immunochemical test (FIT) as part of the Detecting Bowel Cancer in CKD (DETECT) Study. EXPOSURE: Baseline characteristics for patients at the time of study enrollment were ascertained, including duration of CKD, comorbidities, and medications. OUTCOME: Advanced colorectal neoplasia was identified through a 2-step verification process with colonoscopy following positive FIT and 2-year clinical follow-up for all patients. ANALYTICAL APPROACH: Potential factors associated with advanced colorectal neoplasia were explored using multivariable logistic regression. Sensitivity analyses were performed using grouped LASSO (least absolute shrinkage and selection operator) logistic regression. RESULTS: Among 1,706 patients who received FIT-based screening-791 with CKD stages 3-5 not receiving kidney replacement therapy (KRT), 418 receiving dialysis, and 497 patients with a functioning kidney transplant-117 patients (6.9%) were detected to have advanced colorectal neoplasia (54 with CKD stages 3-5 without KRT, 34 receiving dialysis, and 29 transplant recipients), including 9 colorectal cancers. The factors found to be associated with advanced colorectal neoplasia included older age (OR per year older, 1.05 [95% CI, 1.03-1.07], P<0.001), male sex (OR, 2.27 [95% CI, 1.45-3.54], P<0.001), azathioprine use (OR, 2.99 [95% CI, 1.40-6.37], P=0.005), and erythropoiesis-stimulating agent use (OR, 1.92 [95% CI, 1.22-3.03], P=0.005). Grouped LASSO logistic regression revealed similar associations between these factors and advanced colorectal neoplasia. LIMITATIONS: Unmeasured confounding factors. CONCLUSIONS: Older age, male sex, erythropoiesis-stimulating agents, and azathioprine were found to be significantly associated with advanced colorectal neoplasia in patients with CKD.

The Increase in Paraoxonase 1 Is Associated With Decrease in Left Ventricular Volume in Kidney Transplant Recipients.

Background: Patients on dialysis have impaired cardiac function, in part due to increased fluid volume and ventricular stress. Restored kidney function through transplantation reduces left ventricular volume in both systole and diastole. We previously reported that the decrease in NT-proB-type natriuretic peptide (NT-proBNP) was associated with a decrease in adiponectin. Paraoxonase 1 (PON1) has been inversely associated with cardiovascular outcomes. We now report the association of changes in PON1 with changes in left ventricular volume and left ventricular mass after kidney transplantation. Design: Patients on dialysis were assessed at baseline and 12 months after kidney transplantation (n = 38). A comparison group of patients on dialysis who were not expected to receive a transplant in the next 24 months were studied (n = 43) to determine if the change of PON1 with kidney transplantation achieved a significance greater than that due to biologic variation. Left ventricular volume and mass were determined by cardiac magnetic resonance imaging. PON1 was measured by arylesterase activity and by mass. Results: PON1 mass and activity were not different between the groups at baseline. Both PON1 mass and activity were increased post-kidney transplantation (p < 0.0001 for change). The change in PON1 mass (p = 0.0062) and PON1 arylesterase activity (p = 0.0254) were inversely correlated with the change in NT-proBNP for patients receiving a kidney transplant. However, only the change in the PON1 mass, and not the change in PON1 arylesterase, was inversely correlated with the change in left ventricular volume (ml/m2.7) (p = 0.0146 and 0.0114 for diastolic and systolic, respectively) and with the change in hemoglobin (p = 0.0042). Conclusion: Both PON1 mass and arylesterase activity are increased by kidney transplantation. The increase in PON1 mass is consistent with a novel relationship to the increase in hemoglobin and decrease in left ventricular volume and NT-proBNP seen when kidney function is restored.

Long-term outcomes following thrombolysis of arteriovenous grafts.

BACKGROUND: Thrombolysis for arteriovenous grafts (AVG) yields high technical success rates, however, long-term outcomes are unclear. We conducted a multicenter retrospective cohort study to analyze 5-year patency rates following AVG thrombolysis. METHODS: All patients who underwent AVG thrombolysis between 2005 and 2015 at three academic hospitals were included. Prospectively maintained institutional nephrology and radiology databases were used to record demographic, clinical, and AVG characteristics. The primary outcome was primary patency, defined as AVG access survival without re-intervention including angioplasty ± stent with/without re-thrombolysis. Secondary outcomes were assisted primary patency and cumulative patency, defined as AVG access survival until re-thrombosis requiring re-thrombolysis or abandonment, respectively. Technical success was defined as restoration of flow with <30% residual stenosis. Patients were followed until 2017. Patency rates were assessed using Kaplan-Meier survival analysis and Cox proportional hazards were calculated to determine associations between covariates and patency loss. RESULTS: Seventy-four patients underwent AVG thrombolysis during the study period with a median follow-up period of 21.4 (IQR 8.3-42.8) months. The average age was 58.6 years with a high rate of comorbidities, including hypertension (82.4%) and diabetes (54.1%). Thrombolysis technical success was 96%. There were 147 re-interventions in 46 patients, of which 98 were re-thrombolysis (mean re-intervention rate of 1.27/patient/year). Primary patency at 1, 3, and 5 years were 43.2%, 20.2%, and 7.7%. Assisted primary patency at 1, 3, and 5 years were 47.5%, 20.2%, and 7.7%. Cumulative patency at 1, 3, and 5 years were 75.0%, 38.8%, and 22.6%. Cox proportional hazards analysis demonstrated no associations between demographic, clinical, and procedural characteristics and patency rates. CONCLUSIONS: Despite a high technical success rate, thrombolysis for AVG dysfunction is associated with poor long-term patency. Future studies are needed to determine risk factors for re-thrombosis to identify patients who will benefit from AVG thrombolysis in the long-term.

MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

BACKGROUND: Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) is a 4-year cluster-randomized clinical trial comparing the effect of using a personalized, temperature-reduced dialysate protocol versus a dialysate temperature of 36.5°C on cardiovascular-related death and hospitalization. Randomization was performed at the level of the dialysis center ("the cluster"). OBJECTIVE: The objective is to outline the statistical analysis plan for the MyTEMP trial. DESIGN: MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial. SETTING: A total of 84 dialysis centers in Ontario, Canada. PATIENTS: Approximately 13 500 patients will have received in-center hemodialysis at the 84 participating dialysis centers during the trial period (April 3, 2017, to March 1, 2021, with a maximum follow-up to March 31, 2021). METHODS: Patient identification, baseline characteristics, and study outcomes will be obtained primarily through Ontario administrative health care databases held at ICES. Covariate-constrained randomization was used to allocate the 84 dialysis centers (1:1) to the intervention group or the control group. Centers in the intervention group used a personalized, temperature-reduced dialysate protocol, and centers in the control group used a fixed dialysate temperature of 36.5°C. OUTCOMES: The primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization (defined as a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in administrative health care databases. The key secondary outcome is the mean drop in intradialytic systolic blood pressure, defined as the patients' predialysis systolic blood pressure minus their nadir systolic blood pressure during the dialysis treatment. Anonymized data on patients' predialysis and intradialytic systolic blood pressure were collected at monthly intervals from each dialysis center. ANALYSIS PLAN: The primary analysis will follow an intent-to-treat approach. The primary outcome will be analyzed at the patient level as the hazard ratio of time-to-first event, estimated from a subdistribution hazards model. Within-center correlation will be accounted for using a robust sandwich estimator. In the primary analysis, patients' observation time will end if they experience the primary outcome, emigrate from Ontario, or die of a noncardiovascular cause (which will be treated as a competing risk event). The between-group difference in the mean drop in intradialytic systolic blood pressure obtained during the dialysis sessions throughout the trial period will be analyzed at the center level using an unadjusted random-effects linear mixed model. TRIAL STATUS: The MyTEMP trial period is April 3, 2017, to March 31, 2021. We expect to analyze and report results by 2023 once the updated data are available at ICES. TRIAL REGISTRATION: MyTEMP is registered with the US National Institutes of Health at clincaltrials.gov (NCT02628366). STATISTICAL ANALYTIC PLAN: Version 1.1 June 15, 2021.

CONTEXTE: L'essai MyTEMP (Major Outcomes with Personalized Dialysate Temperature) est un essai clinique randomisé en grappes d'une durée de 4 ans comparant l'effet d'un protocole de dialysat personnalisé à température réduite par rapport au dialysat à 36,5 °C sur les hospitalisations et les décès dus à des problèmes cardiovasculaires. La répartition aléatoire des sujets a été effectuée au niveau du centre de dialyse (ci-après appelé « groupe ¼). OBJECTIFS: Exposer les grandes lignes du plan d'analyse statistique de l'essai MyTEMP. TYPE D'ÉTUDE: MyTEMP est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. CADRE: L'essai est mené dans 84 centres de dialyse en Ontario (Canada). SUJETS: On estime qu'environ 13 500 patients auront reçu des soins d'hémodialyse dans les 84 centres de dialyse participants au cours de la période de l'essai (3 avril 2017 au 1er mars 2021; suivi maximal jusqu'au 31 mars 2021). MÉTHODOLOGIE: Les résultats et les données concernant l'identification des patients et leurs caractéristiques initiales seront principalement tirés des bases de données administratives du système de santé ontarien tenues par l'ICES. Une répartition aléatoire restreinte par les covariables a été employée pour classer les 84 centres de dialyse (1:1) dans le groupe d'intervention ou le groupe témoin. Le groupe d'intervention a utilisé un protocole personnalisé de dialysat à température réduite et le groupe témoin un dialysat à température fixe (36,5 °C). RÉSULTATS: Le principal critère d'évaluation est la combinaison d'un décès d'origine cardiovasculaire ou d'une hospitalisation majeure liée à la santé cardiovasculaire (définie comme une hospitalisation pour un infarctus du myocarde, une insuffisance cardiaque congestive ou un AVC ischémique) enregistrée dans les bases de données administratives du système de santé. Le principal critère d'évaluation secondaire est la baisse moyenne de la tension artérielle systolique intradialytique, laquelle est définie comme la tension artérielle systolique du patient avant la dialyse moins la tension artérielle systolique minimale pendant la dialyse. Les données anonymisées sur la tension artérielle systolique initiale et la tension artérielle systolique intradialytique des patients ont été colligées à intervalles mensuels dans chaque centre de dialyse. PLAN D'ANALYSE: L'analyse primaire adoptera une approche fondée sur l'intention de traiter. Le principal critère d'évaluation sera analysé au niveau du patient comme le risque relatif de survenue d'un premier événement, estimé à partir d'un modèle de risques de sous-distribution. La corrélation intracentre sera prise en compte à l'aide d'un robuste estimateur sandwich. Dans l'analyse primaire, le temps d'observation des patients prendra fin s'ils présentent le principal critère d'évaluation, s'ils déménagent hors de l'Ontario ou s'ils décèdent d'une cause non cardiovasculaire (qui sera traitée comme un événement à risque concurrentiel). La différence entre les groupes quant à la baisse moyenne de la tension artérielle systolique intradialytique, obtenue pendant les séances de dialyse tout au long de l'essai, sera analysée au niveau du centre avec un modèle linéaire mixte à effets aléatoires non corrigé. STATUT DE L'ESSAI: L'essai MyTEMP couvre la période du 3 avril 2017 au 31 mars 2021. Nous comptons analyser et rendre compte des résultats d'ici 2023, dès que les données mises à jour seront disponibles à l'ICES. ENREGISTREMENT DE L'ESSAI: MyTEMP est enregistré auprès du National Institute of Health des États-Unis sur clincaltrials.gov (NCT02628366).

Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study.

BACKGROUND: Although living kidney donation is safe, some donors experience perioperative complications. OBJECTIVE: This study explored how perioperative complications affected donor-reported health-related quality of life, depression, and anxiety. DESIGN: This research was a conducted as a prospective cohort study. SETTING: Twelve transplant centers across Canada. PATIENTS: A total of 912 living kidney donors were included in this study. MEASUREMENTS: Short Form 36 health survey, Beck Depression Inventory and Beck Anxiety Inventory. METHODS: Living kidney donors were prospectively enrolled predonation between 2009 to 2014. Donor perioperative complications were graded using the Clavien-Dindo classification system. Mental and physical health-related quality of life was assessed with the 3 measurements; measurements were taken predonation and at 3- and 12-months postdonation. RESULTS: Seventy-four donors (8%) experienced a perioperative complication; most were minor (n = 67 [91%]), and all minor complications resolved before hospital discharge. The presence (versus absence) of a perioperative complication was associated with lower mental health-related quality of life and higher depression symptoms 3-month postdonation; neither of these differences persisted at 12-month. Perioperative complications were not associated with any changes in physical health-related quality of life or anxiety 3-month postdonation. LIMITATIONS: Minor complications may have been missed and information on complications postdischarge were not collected. No minimal clinically significant change has been defined for kidney donors across the 3 measurements. CONCLUSIONS: These findings highlight a potential opportunity to better support the psychosocial needs of donors who experience perioperative complications in the months following donation. TRIAL REGISTRATION: NCT00319579 and NCT00936078.

CONTEXTE: Bien que le don vivant d'un rein soit une procédure sécuritaire, certains donneurs souffrent tout de même de complications périopératoires. OBJECTIFS: Cette étude a examiné l'incidence des complications périopératoires sur la qualité de vie liée à la santé et les symptômes de dépression et d'anxiété rapportés par les donneurs. TYPE D'ÉTUDE: Étude de cohorte prospective. CADRE: Douze centers de transplantation à travers le Canada. SUJETS: 912 donneurs vivants d'un rein. MESURES: Un questionnaire abrégé de 36 questions sur l'état de santé, l'inventaire de dépression Beck et l'inventaire d'anxiété Beck. MÉTHODOLOGIE: Les donneurs ont été inscrits avant le don de façon prospective entre 2009 et 2014. Les complications périopératoires des donneurs ont été classées à l'aide du système de classification Clavien-Dindo. La qualité de vie liée à la santé physique et mentale a été évaluée à l'aide des trois outils de mesure; ces mesures ont été faites avant le don, puis 3 et 12 mois après le don. RÉSULTATS: Au total, 74 donneurs (8 %) ont souffert d'une complication périopératoire; la plupart étaient mineures (n = 67 [91 %]) et ont été résolues avant le congé de l'hôpital. La présence (par rapport à l'absence) d'une complication périopératoire a été associée à une plus faible qualité de vie liée à la santé mentale et à des symptômes de dépression plus graves 3 mois après le don; aucune de ces différences n'a persisté après 12 mois. Les complications périopératoires n'ont pas été associées à des changements dans la qualité de vie liée à la santé physique ou à l'anxiété 3 mois après le don. LIMITES: Certaines complications mineures ont pu être manquées. L'information sur les complications survenues après le congé n'a pas été recueillie. Dans les trois outils de mesure, aucune variation minimale cliniquement significative n'a été définie pour les donneurs d'un rein. CONCLUSION: Ces résultats soulignent une occasion de mieux répondre aux besoins psychosociaux des donneurs d'un rein qui présentent des complications périopératoires dans les mois suivant le don.