Design of therapeutic education workshops for home haemodialysis in a patient-centered chronic kidney diseases research: a qualitative study.

RATIONALE & OBJECTIVE: A quarter of patients do not receive any information on the modalities of renal remplacement therapy (RRT) before its initiation. In our facility, we provide therapeutic education workshops for all RRT except for home hemodialysis (HHD). The objectives of this study were to identify and describe the needs of CKD patients and caregivers for RRT with HHD and design therapeutic education workshops. SETTING & PARTICIPANTS: Two sequential methods of qualitative data collection were conducted. Interviews with patients treated with HHD and doctors specialized in HHD were performed to define the interview guide followed by semi-structured interviews with the help of HHD patients from our center. ANALYTIC APPROACH: Thematic analysis was conducted and were rooted in the principles of qualitative analysis for social scientists. Data were analyzed by two investigators. Transcribed interviews were entered into RQDA 3.6.1 software for data organization and coding purposes (Version 3.6.1). RESULTS: In total, five interviews were performed. We identified six themes related to the barriers, facilitators, and potential solutions to home dialysis therapy: (1) HHD allows autonomy and freedom with constraints, (2) safety of the care environment, (3) the caregiver and family environment, (4) patient's experience and experiential knowledge, (5) self-care experience and impact on life, and (6) factors that impact the choice of treatment with HHD. We designed therapeutic education workshops in a group of patients and caregivers. CONCLUSIONS: Our study confirmed previous results obtained in literature on the major barriers, facilitators, and potential solutions to HHD including the impact of HHD on the caregiver, the experiences of patients already treated with HHD, and the role of nurses and nephrologists in informing and educating patients. A program to develop patient-to-patient peer mentorship allowing patients to discuss their dialysis experience may be relevant.

Patient-reported outcome measures in hemodialysis patients: results of the first multicenter cross-sectional ePROMs study in France.

BACKGROUND: Kidney failure with replacement therapy and hemodialysis are associated with a decrease in quality of life (QOL). Self-reported QOL symptoms are not always prioritized by the medical team, potentially leading to conflicting priorities with patients. Electronic patient-reported outcome measures (ePROMs) allow physicians to better identify these symptoms. The objective was to describe the prevalence of symptoms self-reported by hemodialysis (HD) patients. METHODS: A multicenter cross-sectional study was conducted in three HD centers. Patients were included if they were 18 years old or over treated with HD for at least 3 months in a center. Data were collected by the patient via a self-administered ePROMs questionnaire. Data included patient characteristics, post-dialysis fatigue and intensity, recovery time after a session, perceived stress, impaired sleep the day before the dialysis session, current state of health and the change from the past year. A multivariate analysis was conducted to identify relations between symptoms. RESULTS: In total, we included 173 patients with a mean age of 66.2 years, a mean ± SD hemodialysis duration of 48.9 ± 58.02 months. The prevalence of fatigue was 72%. 66% had a high level of stress (level B or C). Recovery time was more than 6 h after a HD session for 25% of patients and 78% declared they had a better or unchanged health status than the previous year. Sleep disturbance was associated with cardiovascular comorbidities (OR 5.08 [95% CI, 1.56 to 16.59], p = 0.007). CONCLUSIONS: Fatigue and stress were the main symptoms reported by HD patients. The patient's care teams should better consider these symptoms.

[Psychological impact of lockdown and the COVID-19 epidemic on haemodialysis patients and carers in France]. / Répercussions psychologiques du confinement et de l'épidémie à COVID-19 chez les patients et soignants en hémodialyse en France.

INTRODUCTION: The health crisis linked to the COVID-19 epidemic has required lockdown measures in France and changes in practices in dialysis centers. The objective was to assess the depressive and anxiety symptoms during lockdown in hemodialysis patients and their caregivers. METHODS: We sent, during lockdown period, between April and May 2020, self-questionnaires to voluntary subjects (patients and caregivers), treated by hemodialysis or who worked in hemodialysis in one of the 14 participating centers in France. We analyzed their perception of dialysis sessions (beneficial or worrying), their stress level (VAS rated from 0 to 10), their anxiety and depressive symptoms (Hospital anxiety and depression scale). Factors associated with stress, anxiety and depression were analyzed with multiple linear regression models. RESULTS: 669 patients and 325 caregivers agreed to participate. 70 % of participants found it beneficial to come to dialysis during confinement. The proportions of subjects with a stress level ≥ 6 linked to the epidemic, confinement, fear of contracting COVID-19 and fear of infecting a loved one were respectively 23.9%, 26.2%, 33.4% and 42%. 39.2% presented with certain (13.7%) or doubtful (19.2%) anxious symptoms. 21.2% presented a certain (7.9%) or doubtful (13.3%) depressive symptomatology. Age, gender, history of psychological disorders and perception of dialysis sessions were associated with levels of stress, anxiety and depression. CONCLUSION: During the lockdown period, in France, the majority of hemodialysis patients and caregivers found it beneficial to come to dialysis. One in three subjects had anxiety symptoms and one in five subjects had depressive symptoms.

Evaluation of the efficacy of an interdialytic "ethanol 40% v/v - enoxaparin 1000 U/mL" lock solution to prevent tunnelled catheter infections in chronic hemodialysis patients: a multi-centre, randomized, single blind, parallel group study.

BACKGROUND: Tunnelled dialysis catheter (TC) infections are a major health complication and are associated with increased antibiotic consumption, hospital stays, health costs and mortality. Experimental data provide evidence that Ethenox, a mixture of enoxaparine 1000 U/mL in 40% v/v ethanol, could be a promising lock solution. The aim of the study is to compare an interdialytic lock solution of Ethenox with reference lock solutions, unfractionated heparin (UFH) or citrate 4% for the prevention of TCI in hemodialysis patients. METHOD: This study will monitor a multicentre, prospective, single blind, randomized, controlled, parallel group trial. The main inclusion criteria are patients > 18 years old with end-stage renal disease, treated with chronic hemodialysis/hemodiafiltration three times a week, with incident or prevalent non-impregnated internal jugular TCs inserted for at least 2 weeks and able to give informed consent. Exclusion criteria are TCI in the previous 4 weeks and anti-infective treatment for TCI in the previous 2 weeks. Patients will be randomized to receive either study treatment Ethenox in the intervention group or reference solutions in the control group, unfractionated heparin (UFH) or citrate 4% w/v according to usual practice. The primary outcome measure will be time to first TCIs assessed by an endpoint adjudication committee blinded to the study arm according to predefined criteria. Patients will receive the study treatment for up to 12 months. Intention-to-treat analysis of the primary endpoint will be performed with a marginal Cox proportional hazard model. Prospective power calculations indicate that the study will have 90% statistical power to detect a clinical significant two-fold increase in median infection-free survival if 200 patients are recruited into each arm over a period of 24 months. DISCUSSION: Firm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients. The results of this study will allow the development of new guidelines based on a high level of evidence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03083184 , date of registration March 17 2017 and European Clinical Trials Database Identifier: EudraCT 2016-A00180-51), date of registration July 11 2016.

Impact of renal dysfunction on the management and outcome of acute heart failure: results from the French prospective, multicentre, DeFSSICA survey.

OBJECTIVES: Cardiorenal syndrome (CRS) is the combination of acute heart failure syndrome (AHF) and renal dysfunction (creatinine clearance (CrCl) ≤60 mL/min). Real-life data were used to compare the management and outcome of AHF with and without renal dysfunction. DESIGN: Prospective, multicentre. SETTING: Twenty-six academic, community and regional hospitals in France. PARTICIPANTS: 507 patients with AHF were assessed in two groups according to renal function: group 1 (patients with CRS (CrCl ≤60 mL/min): n=335) and group 2 (patients with AHF with normal renal function (CrCl >60 mL/min): n=172). RESULTS: Differences were observed (group 1 vs group 2) at admission for the incidence of chronic heart failure (56.42% vs 47.67%), use of furosemide (60.9% vs 52.91%), insulin (15.52% vs 9.3%) and amiodarone (14.33% vs 4.65%); additionally, more patients in group 1 carried a defibrillator (4.78% vs 0%), had ≥2 hospitalisations in the last year (15.52% vs 5.81%) and were under the care of a cardiologist (72.24% vs 61.63%). Clinical signs were broadly similar in each group. Brain-type natriuretic peptide (BNP) and BNP prohormone were higher in group 1 than group 2 (1157.5 vs 534 ng/L and 5120 vs 2513 ng/mL), and more patients in group 1 were positive for troponin (58.2% vs 44.19%), had cardiomegaly (51.04% vs 37.21%) and interstitial opacities (60.3% vs 47.67%). The only difference in emergency treatment was the use of nitrates, (higher in group 1 (21.9% vs 12.21%)). In-hospital mortality and the percentage of patients still hospitalised after 30 days were similar between groups, but the median stay was longer in group 1 (8 days vs 6 days). CONCLUSIONS: Renal impairment in AHF should not limit the use of loop diuretics and/or vasodilators, but early assessment of pulmonary congestion and close monitoring of the efficacy of conventional therapies is encouraged to allow rapid and appropriate implementation of alternative therapies if necessary.

[Access to kidney transplantation's waiting list: Setting up a clinical pathway]. / Accès à la liste d'attente de transplantation rénale : mise en place d'un chemin clinique.

Early information about the kidney transplant is recommended to begin quickly the process of registration on the kidney transplantation waiting list, even for the patients not dialyzed at stage V of the renal insufficiency. It is a strategic choice for the patient care. From the arrival of all the patients in our center of dialysis, a systematic evaluation of the access to the kidney transplant waiting list is organized thanks to a clinical pathway. The impact of this new organization was estimated at 18 months with regard to the information about the kidney transplant transmitted to the patient, of the time required for the assessment of pre-kidney transplant evaluation, and of putting in contraindication. On 78 incident patients, 64 received the information concerning the kidney transplant. After 18 months, 50 clinical pathways are finalized at the time of the analysis among which 25 with a period lower than 6 days and 25 with a median of 169 days. A significant difference of age exists between both groups. The main causes of definitive medical contraindications were estimated. Twenty-two percent of the clinical pathway finalized is awaiting lifting of temporary contraindication. The management of the patient is improved, due to motivation of all the medical teams and a considerable work of coordination between the secretarial department and the department of transplantation in teaching hospital.

Anemia normalization in patients with type 2 diabetes and chronic kidney disease: results of the NEPHRODIAB2 randomized trial.

STATEMENTS OF THE PROBLEM: Correction of anemia in type 2 diabetes (T2DM) patients with chronic kidney disease stages 3-4 may slow the decline of kidney function but may increase cardiovascular risk through higher hematocrit. The NEPHRODIAB2 study was designed to assess efficacy and safety of complete hemoglobin (Hb) normalization in these patients. METHODS: We randomly assigned 89 T2DM patients with an estimated glomerular filtration rate (eGFR; abbreviated 175 Modification of Diet in Renal Disease formula) of 25 to 60 ml/min per 1.73 m(2) and moderate anemia (Hb, 100-129 g/l) to a target Hb value in subnormal range (110-129g/l, group 1, n=43) or normal range (130-149 g/l, group 2, n=46). The primary end point was eGFR decline after 2 years of follow-up. Secondary end points included iron and erythropoietin dosage, quality of life (Medical Outcomes Study 36-item Short-Form Health Survey scores) and adverse events. RESULTS: Six months after randomization, the mean Hb levels were <120 g/l in group 1 and >130 g/l in group 2 (P<.05 at 6, 12, 18 and 24 months). Blood pressure, 24-h proteinuria and HbA1c did not differ during follow-up (P>.05). Two-year declines in eGFR were -8.7±12.2 in group 1 and -5.1±7.8 ml/min per 1.73 m(2) in group 2 (P=.29). Mean weekly use of erythropoietin was 7.8±11.6 µg in group 1 and 30.1±33.6 µg in group 2 (P<.0001). There was no significant difference regarding Medical Outcomes Study 36-item Short-Form Health Survey score change or adverse event occurrence. CONCLUSIONS: In this trial, normalization of Hb level in T2DM patients with chronic kidney disease was safe but did not significantly slow renal function decline and increased treatment cost due to erythropoietin use.