Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial.

INTRODUCTION: Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit. METHODS AND ANALYSIS: The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0-3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient. ETHICS AND DISSEMINATION: The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: NCT03862859, EUDRA-CT 2018-000484-86 and CTIS ID 2022-502500-75-00.

The short-term effect of hemodialysis on the level of high-sensitive cardiac troponin T - A systematic review.

INTRODUCTION: Patients with end-stage renal disease (ESRD) have an increased risk of cardiovascular disease, but interpreting cardiac troponin is difficult in this population. The effect of renal replacement therapy (RRT) is important to consider when interpreting serial cardiac troponin T (cTnT) results for patients with ESRD suspected of acute coronary syndrome (ACS). The aim of this systematic review is to answer how low-flux hemodialysis (LF-HD), high-flux hemodialysis (HF-HD), and hemodiafiltration (HDF) affect the blood concentration of high-sensitive cardiac troponin T (hs-cTnT). METHOD: Several databases were searched and identified records were evaluated independently by two of the authors. Pre- and postdialysis hs-cTnT concentrations together with other relevant data were extracted from the included studies. The quality (potential bias and applicability issues) were assessed for each of the included studies. RESULTS: The literature search identified 2,540 records and 15 studies were included. The relative pre- to postdialysis change of hs-cTnT varied from -41 to 29%. LF-HD increased the hs-cTnT concentration with relative changes between 2 and 17%. HDF decreased the concentration with relative changes from -41% to -9%. Both increases and decreases were seen for HF-HD (-16% to 12%). DISCUSSION/CONCLUSION: In this systematic review, we found LF-HD to increase the hs-cTnT concentration and HDF to decrease the concentration. Results for HF-HD and unspecified HD are more heterogeneous. Because of the differences between the included studies, a meta-analysis was not meaningful. This systematic review can help with the assessment of patients with ESRD suspected of ACS in relation to hemodialysis/HDF treatment.

Prevalence and incidence of chronic kidney disease stage 3-5 - results from KidDiCo.

BACKGROUND: Chronic kidney disease (CKD) is a global challenge. CKD prevalence estimation is central to management strategies and prevention. It is necessary to predict end stage kidney disease (ESKD) and, subsequently, the burden for healthcare systems. In this study we characterize CKD stage 3-5 prevalence and incidence in a cohort covering the majority of the Region of Southern Denmark and investigate individuals' demographic, socioeconomic, and comorbidity status. METHODS: We used data from the Kidney Disease Cohort (KidDiCo) combining laboratory data from Southern Denmark with Danish national databases. Chronic kidney disease was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. RESULTS: The prevalence varied between 4.83 and 4.98% and incidence rate of CKD was 0.49%/year. The median age was 76.4 years. The proportion of individuals with CKD stage 3-5 in the entire population increased consistently with age. The percentage of women in the CKD 3-5 group was higher than in the background population. Diabetes mellitus, hypertension and cardiovascular disease were more prominent in patients with CKD. CKD stage 5 and ESKD were more frequent as incident CKD stages in the 18-49 year olds when compared to older individuals. CKD patients tended to have a lower socioeconomic status. CONCLUSION: Chronic kidney disease stage 3-5 is common, especially in the elderly. Patients with CKD stage 3-5 are predominantly female. The KidDiCo data suggests an association between lower socioeconomic status and prevalence of CKD.

Feasibility and First Experiences from an Online Kidney School for Patients with Chronic Kidney Disease.

Objectives: To examine patients' and relatives' experiences with participation in an online kidney school (OKS) and its influence on their choice of treatment modality; furthermore, to report on healthcare professionals' (HCPs) first experiences with OKS. Methods: A mixed-methods design with parallel data collection involving two questionnaires for participants, including patients and relatives and a focus group discussion (FGD) with HCPs. Results: The OKS was feasible, and overall, patients and relatives were satisfied. Participation in the OKS increased the percentage of those who felt ready to make a decision regarding treatment. One over-arching theme (evolvement of the online kidney school over time) and three sub-themes (concerns and perceived barriers, facilitators, and benefits and future possibilities) emerged from the FGD. Conclusions: The OKS proved feasible, was well-accepted, and increased participants' abilities to choose a preferred treatment modality. HCPs displayed initial concerns regarding the quality of the OKS and worried about the practicality of conducting the OKS. They experienced a feeling of something being lost. However, over time, HCPs developed strategies to tackle initial concerns and discovered that patients were more capable of participating than they had anticipated.

[Christmas article: Christmas music might just be the secret behind the peace of Christmas ].

INTRODUCTION: Christmas, which is just around the corner, is associated with stress in Danish homes. Therefore, it is important to find interventions that reduce stress levels. Classical music is known to have a soothing effect as it reduces systolic blood pressure and increases quality of life. However, whether or not Christmas music can bring about the same effect is unknown. Therefore, the purpose of this study was to examine whether or not Christmas music has a calming effect. METHODS: The design was a classical intervention study, in which participants were subjected to Christmas music. Blood pressure was measured prior to, and after, the intervention, and a questionnaire was completed regarding demographical questions and questions about one's attitude to Christmas and Christmas spirit. We used a paired t-test to test the primary outcome and a p-value ≤ 0.05 was considered statistically significant. RESULTS: Ten participants took part in the study, of whom 8 were female (and 1 unknown). The systolic blood pressure fell by 3.5 mmHg (p = 0.12) and the Christmas mood which was on an average of 5 at the beginning of the study rose by 0.8 point following the intervention. CONCLUSION: In this study, we displayed that Christmas music has the potential to reduce blood pressure and increase the Christmas spirit. Therefore, we recommend that one plays Christmas music throughout the month of December to reduce stress levels and bring us whole skinned and in high spirits through the Christmas season. FUNDING: none. TRIAL REGISTRATION: none.

Rate and Risk Factors of Acute Myocardial Infarction after Debut of Chronic Kidney Disease-Results from the KidDiCo.

Chronic kidney disease (CKD) is a known risk factor for cardiovascular disease, including acute myocardial infarction. However, whether this risk is only associated with severe kidney disease or is also related to mildly impaired kidney function is still under debate. The incidence rate and risk factors of incident acute myocardial infarction (AMI) in patients with CKD are sparse. Potential differences in risk factor profiles between CKD patients with incident AMI and CKD patients with a prior AMI have not been sufficiently investigated. Furthermore, important factors such as albuminuria and socio-economic factors are often not included. The primary aim of this study was to establish the incidence rate of AMI after CKD debut. Secondly, to evaluate the importance of different CKD stages and the risk of having an AMI. Finally, to identify individuals at risk for AMI after CKD debut adjusted for prevalent AMI. Based on data from the kidney disease cohort of Southern Denmark (KidDiCo), including 66,486 CKD patients, we established incidence rates and characteristics of incident AMI among patients within a 5-year follow-up period after CKD debut. A Cox regression was performed to compute the cause-specific hazard ratios for the different risk factors. The incidence rate for CKD stage G3−5 patients suffering acute myocardial infarction is 2.5 cases/1000 people/year. In patients without a previous myocardial infarction, the risk of suffering a myocardial infarction after CKD debut was only significant in CKD stage G4 (HR = 1.402; (95% CI: 1.08−1.81); p-value = 0.010) and stage G5 (HR = 1.491; (95% CI: 1.01−2.19); p-value = 0.042). This was not the case in patients who had suffered an acute myocardial infarction prior to their CKD debut. In this group, a previous myocardial infarction was the most critical risk factor for an additional myocardial infarction after CKD debut (HR = 2.615; (95% CI: 2.241−3.05); p-value < 0.001). Irrespective of a previous myocardial infarction, age, male sex, hypertension, and a low educational level were significant risk factors associated with an acute myocardial infarction after CKD debut. The incidence rate of AMI in patients with CKD stage G3−5 was 2.5 cases/1000 people/year. Risk factors associated with incident AMI in CKD stage G3−5 patients were CKD stage, age, and hypertension. Female sex and higher educational levels were associated with a lower risk for AMI. Prior AMI was the most significant risk factor in patients with and without previous AMI before fulfilling CKD stage G3−5 criteria. Only age, sex, and a medium-long educational level were significant risk factors in this group.

Referral rate of chronic kidney disease patients to a nephrologist in the Region of Southern Denmark: results from KidDiCo.

Background: Data on the referral rate of chronic kidney disease (CKD) patients to specialists are sparse. Investigating referral rates and characterizing patients with kidney disease not followed by a nephrologist are relevant for future measures in order to optimize public health and guideline implementation. Methods: Data were extracted from the Kidney Disease Cohort of Southern Denmark (KidDiCo). Referral rates for all incident CKD patients below 60 mL/min/1.73 m² and referral rates according to the KDIGO guidelines based on glomerular filtration rates below 30 mL/min/1.73 m² were calculated. Information on contact with one of the nephrologist outpatient clinics in the Region of Southern Denmark was collected from the Danish National Patient Registry. The individual follow-up time for nephrology contact was 12 months. Additional data were accessed via the respective national databases. CKD patients on dialysis and kidney transplanted patients were excluded. Results: A total of 3% of patients with an eGFR <60 mL/min/1.73 m²-16% of patients with an eGFR <30 mL/min/1.73 m² and 35% of patients with an eGFR <15 mL/min/1.73 m² were in contact with a nephrologist in the outpatient settings. Younger age, male sex, diabetes, hypertension, higher education and proximity to a nephrology outpatient clinic increased the chance of nephrology follow-up. Conclusion: Only a small fraction of CKD patients are followed by a nephrologist. More studies should be performed in order to find out which patients will profit the most from renal referral and how to optimize the collaboration between nephrologists and general practitioners.

mHealth education for patients with chronic kidney disease: protocol for a scoping review.

INTRODUCTION: More than 10% of the population worldwide is affected by chronic kidney disease (CKD). Despite many promising indications regarding the use of mHealth education for patients with CKD, there is still little evidence regarding the feasibility, effectiveness outcomes and outcome measures. Therefore, we will conduct a scoping review to examine the currently available evidence on mHealth education for patients with CKD and, thus, explore the existing evidence regarding feasibility, effectiveness outcomes and outcome measures, patient and/or provider perception and implementation challenges. METHODS AND ANALYSIS: A scoping review will be conducted in accordance with Joanna Briggs Institute Manual for Evidence Synthesis chapter on scoping reviews.MEDLINE, Embase, CINAHL and PsycINFO will be searched. The search strategy will consist of blocks, which have been adopted and modified from former Cochrane reviews. Two independent reviewers will screen studies. Characteristics of the included studies, both quantitative and qualitative, will be reported using quantitative descriptive statistics. Quantitative results will be grouped by objectives (feasibility, effectiveness outcomes and outcome measures, patient perception and implementation challenges), types of intervention and characteristics of participants. Qualitative results will be organised into categories using an iterative process, as suggested by Pollock et al. ETHICS AND DISSEMINATION: As this scoping review does not involve primary data collection, ethical permission is unnecessary. Results of the scoping review will be published in an international peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: Open Science Framework (https://osf.io/gxkeh/).

First-year mortality in incident dialysis patients: results of the Peridialysis study.

BACKGROUND: Controversy surrounds which factors are important for predicting early mortality after dialysis initiation (DI). We investigated associations of predialysis course and circumstances affecting planning and execution of DI with mortality following DI. METHODS: Among 1580 patients participating in the Peridialysis study, a study of causes and timing of DI, we registered features of predialysis course, clinical and biochemical data at DI, incidence of unplanned suboptimal DI, contraindications to peritoneal dialysis (PD) or hemodialysis (HD), and modality preference, actual choice, and cause of modality choice. Patients were followed for 12 months or until transplantation. A flexible parametric model was used to identify independent factors associated with all-cause mortality. RESULTS: First-year mortality was 19.33%. Independent factors predicting death were high age, comorbidity, clinical contraindications to PD or HD, suboptimal DI, high eGFR, low serum albumin, hyperphosphatemia, high C-reactive protein, signs of overhydration and cerebral symptoms at DI. Among 1061 (67.2%) patients who could select dialysis modality based on personal choice, 654 (61.6%) chose PD, 368 (34.7%) center HD and 39 (3.7%) home HD. The 12-months survival did not differ significantly between patients receiving PD and in-center HD. CONCLUSIONS: First-year mortality in incident dialysis patients was in addition to high age and comorbidity, associated with clinical contraindications to PD or HD, clinical symptoms, hyperphosphatemia, inflammation, and suboptimal DI. In patients with a "free" choice of dialysis modality based on their personal preferences, PD and in-center HD led to broadly similar short-term outcomes.

Expectations and Experiences of Patients Recently Initiated to Centre-Based Dialysis Treatment.

Existing studies display a huge disparity in terms of the number of patients who regret having engaged in dialysis. Modifiable care processes such as providing sufficient information and education prior to decision-making have been shown to have a greater impact on patient satisfaction. Despite the importance of regret as a measure of the quality of the dialysis decision-making process, few studies have examined regret following dialysis initiation. Aim: To explore the expectations and experiences of patients who have recently started centre-based dialysis treatment. Methods: A qualitative explorative study of centre-based dialysis patients was performed. Data were collected using focus group discussions of 2-4 patients. The study was guided by interpretive description and thematic analysis was used to analyse data. Results: Three focus group discussions were performed. Participants (n = 8) consisted of six men and two women aged 54 to 80 years of age with a median age of 72. Three themes emerged from the data: 1. transition from being a non-dialysis patient to becoming a dialysis patient, 2. physical condition following initiation of dialysis treatment, and 3. limitations and social disruptions. Conclusion: The initiation of dialysis disrupted daily life in terms of fluctuating fatigue, strict schedules, and time lost. There was a loss of independence, and participants did not view dialysis as an active choice. Nurses may have a significant impact on the perception of dialysis. This study highlights the need for further research to develop interventions to support newly initiated centre-based dialysis patients to transition from non-dialysis to dialysis patients.

Kidney Disease Cohort (KidDiCo) of Southern Denmark: Design, Coverage, Generalizability and Implications for Use.

BACKGROUND: This article provides a description of a large register of a population from the Region of Southern Denmark, the Kidney Disease Cohort (KiDiCo). Coverage and representativeness according to gender and education level are discussed. METHODS: Data for KiDiCo were obtained using laboratory databases from participating laboratories in the Region of Southern Denmark and were linked to individual personal 10-digit personal identification numbers. The study population includes individuals over 18 years of age living in Denmark, whose serum creatinine was analysed in one of the 27 participating laboratories in the Region of Southern Denmark during the period of 8 years from 1st January 2006 to 31st December 2013. Individually linked data consist of diagnosis codes, date and cause of death, dispensed medicine data, socioeconomic data and demographic data. RESULTS: In total, n = 669,929 individuals had their blood tested for creatinine between 2007 and 2013 in a defined geographical area. The estimated geographical coverage was 78%. The median age of the background population was 6 years lower. The cohort had a slightly higher percentage of females (53%) compared to the background population (49%). Differences in educational levels reflect the minor age gap. CONCLUSION: Based on coverage of 78% together with similar characteristics in terms of gender and age, the KiDiCo is a representative cohort of patients in the Region of Southern Denmark. Combining laboratory data with high-quality Danish administrative registers makes diverse research feasible.

Choice of dialysis modality among patients initiating dialysis: results of the Peridialysis study.

BACKGROUND: In patients with end-stage kidney disease (ESKD), home dialysis offers socio-economic and health benefits compared with in-centre dialysis but is generally underutilized. We hypothesized that the pre-dialysis course and institutional factors affect the choice of dialysis modality after dialysis initiation (DI). METHODS: The Peridialysis study is a multinational, multicentre prospective observational study assessing the causes and timing of DI and consequences of suboptimal DI. Clinical and biochemical data, details of the pre-dialytic course, reasons for DI and causes of the choice of dialysis modality were registered. RESULTS: Among 1587 included patients, 516 (32.5%) were judged unsuitable for home dialysis due to contraindications [384 ( 24.2%)] or no assessment [106 (6.7%); mainly due to late referral and/or suboptimal DI] or death [26 (1.6%)]. Older age, comorbidity, late referral, suboptimal DI, acute illness and rapid loss of renal function associated with unsuitability. Of the remaining 1071 patients, 700 (65.4%) chose peritoneal dialysis (61.7%) or home haemodialysis (HD; 3.6%), while 371 (34.6%) chose in-centre HD. Somatic differences between patients choosing home dialysis and in-centre dialysis were minor; factors linked to the choice of in-centre dialysis were late referral, suboptimal DI, acute illness and absence of a 'home dialysis first' institutional policy. CONCLUSIONS: Given a personal choice with shared decision making, 65.4% of ESKD patients choose home dialysis. Our data indicate that the incidence of home dialysis potentially could be further increased to reduce the incidence of late referral and unplanned DI and, in acutely ill patients, by implementing an educational programme after improvement of their clinical condition.

Suboptimal dialysis initiation is associated with comorbidities and uraemia progression rate but not with estimated glomerular filtration rate.

BACKGROUND: Despite early referral of uraemic patients to nephrological care, suboptimal dialysis initiation (SDI) remains a common problem associated with increased morbimortality. We hypothesized that SDI is related to pre-dialysis care. METHODS: In the 'Peridialysis' study, time and reasons for dialysis initiation (DI), clinical and biochemical data and centre characteristics were registered during the pre- and peri-dialytic period for 1583 end-stage kidney disease patients starting dialysis over a 3-year period at 15 nephrology departments in the Nordic and Baltic countries to identify factors associated with SDI. RESULTS: SDI occurred in 42%. Risk factors for SDI were late referral, cachexia, comorbidity (particularly cardiovascular), hypoalbuminaemia and rapid uraemia progression. Patients with polycystic renal disease had a lower incidence of SDI. High urea and C-reactive protein levels, acidosis and other electrolyte disorders were markers of SDI, independently of estimated glomerular filtration rate (eGFR). SDI patients had higher eGFR than non-SDI patients during the pre-dialysis period, but lower eGFR at DI. eGFR as such did not predict SDI. Patients with comorbidities had higher eGFR at DI. Centre practice and policy did not associate with the incidence of SDI. CONCLUSIONS: SDI occurred in 42% of all DIs. SDI was associated with hypoalbuminaemia, comorbidity and rate of eGFR loss, but not with the degree of renal failure as assessed by eGFR.

[Deadly outcome after ingestion of squirting cucumber].

In this case report, an 83-year-old woman with dementia was admitted to hospital with vomiting and diarrhoea. Her medical history included dementia, atrial fibrillation and seizures. She had accidentally ingested a kind of "fruit", which was used as part of a flower decoration in her room. When admitted, she was in hypovolaemic shock and hypoxic. The ingested "fruit" was identified as squirting cucumber: Ecballium elaterium, which is known to cause vomiting and diarrhoea, according to the Danish poison centre. The patient's condition deteriorated despite intravenously given fluid and antibiotic treatment for a suspected aspiration pneumonia. She died two hours after admission.

Why do physicians prescribe dialysis? A prospective questionnaire study.

INTRODUCTION: The incidence of unplanned dialysis initiation (DI) with consequent increased comorbidity, mortality and reduced modality choice remains high, but the optimal timing of dialysis initiation (DI) remains controversial, and there is a lack of studies of specific reasons for DI. We investigated why and when physicians prescribe dialysis and hypothesized that physician motivation for DI is an independent factor which may have clinical consequences. METHODS: In the Peridialysis study, an ongoing multicenter prospective study assessing the causes and timing of DI and consequences of unplanned dialysis, physicians in 11 hospitals were asked to describe their primary, secondary and further reasons for prescribing DI. The stated reasons for DI were analyzed in relation to clinical and biochemical data at DI, and characteristics of physicians. RESULTS: In 446 patients (median age 67 years; 38% females; diabetes 25.6%), DI was prescribed by 84 doctors who stated 23 different primary reasons for DI. The primary indication was clinical in 63% and biochemical in 37%; 23% started for life-threatening conditions. Reduced renal function accounted for only 19% of primary reasons for DI but was a primary or contributing reason in 69%. The eGFR at DI was 7.2 ±3.4 ml/min/1.73 m2, but varied according to comorbidity and cause of DI. Patients with cachexia, anorexia and pulmonary stasis (34% with heart failure) had the highest eGFR (8.2-9.8 ml/min/1.73 m2), and those with edema, "low GFR", and acidosis, the lowest (4.6-6.1 ml/min/1.73 m2). Patients with multiple comorbidity including diabetes started at a high eGFR (8.7 ml/min/1.73 m2). Physician experience played a role in dialysis prescription. Non-specialists were more likely to prescribe dialysis for life-threatening conditions, while older and more experienced physicians were more likely to start dialysis for clinical reasons, and at a lower eGFR. Female doctors started dialysis at a higher eGFR than males (8.0 vs. 7.1 ml/min/1.73 m2). CONCLUSIONS: DI was prescribed mainly based on clinical reasons in accordance with current recommendations while low renal function accounted for only 19% of primary reasons for DI. There are considerable differences in physicians´ stated motivations for DI, related to their age, clinical experience and interpretation of biochemical variables. These differences may be an independent factor in the clinical treatment of patients, with consequences for the risk of unplanned DI.