Dataset Information

Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K).

ABSTRACT:

Background

Hyperkalaemia is a known risk factor for cardiac arrhythmia and mortality in patients on haemodialysis. Despite standard adequate haemodialysis, hyperkalaemia is common in patients with end-stage renal disease (ESRD) at interdialytic intervals. Data on hyperkalaemia burden and its effects on dialysis patterns and serum potassium (sK) fluctuations in patients on haemodialysis in China remain limited. The prospective, observational cohort study (PRECEDE-K; NCT04799067) investigated the prevalence, recurrence, and treatment patterns of hyperkalaemia in Chinese patients with ESRD on haemodialysis.

Methods

Six hundred adult patients were consecutively enrolled from 15 secondary and tertiary hospitals in China. In this interim analysis, we report the baseline characteristics of the cohort, the prevalence of predialysis hyperkalaemia (sK > 5.0 mmol/L), and the trends in serum-dialysate potassium gradient and intradialytic sK shift at Visit 1 (following a long interdialytic interval [LIDI]).

Results

At baseline, most patients (85.6%) received three-times weekly dialysis; mean duration was 4.0 h. Mean urea reduction ratio was 68.0% and Kt/V was 1.45; 60.0% of patients had prior hyperkalaemia (previous 6 months). At Visit 1, mean predialysis sK was 4.83 mmol/L, and 39.6% of patients had hyperkalaemia. Most patients (97.7%) received a dialysate potassium concentration of 2.0 mmol/L. The serum-dialysate potassium gradient was greater than 3 mmol/L for over 40% of the cohort (1- < 2, 2- < 3, 3- < 4, and ≥ 4 mmol/L in 13.6%, 45.1%, 35.7%, and 5.2% of patients, respectively; mean: 2.8 mmol/L). The intradialytic sK reduction was 1- < 3 mmol/L for most patients (0- < 1, 1- < 2, 2- < 3, and ≥ 3 mmol/L in 24.2%, 62.2%, 12.8%, and 0.9% of patients, respectively; mean: 1.4 mmol/L).

Conclusions

Hyperkalaemia after a LIDI was common in this real-world cohort of Chinese patients despite standard adequate haemodialysis, and led to large serum-dialysate potassium gradients and intradialytic sK shifts. Previous studies have shown hyperkalaemia and sK fluctuations are highly correlated with poor prognosis. Effective potassium-lowering treatments should be evaluated for the improvement of long-term prognosis through the control of hyperkalaemia and sK fluctuations.

Trial registration

ClinicalTrials.gov, NCT04799067.

SUBMITTER: Ni Z

PROVIDER: S-EPMC10411008 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K).

Ni Zhaohui Z Jin Haijiao H Lu Renhua R Zhang Lihong L Yao Li L Shao Guojian G Zuo Li L Qin Shuguang S Zhang Xinzhou X Zhang Qinghong Q Yu Weimin W Luo Qun Q Ren Yuqing Y Peng Hui H Xiao Jie J Yang Qiongqiong Q Chen Qinkai Q Shi Yifan Y

BMC nephrology 20230809 1

<h4>Background</h4>Hyperkalaemia is a known risk factor for cardiac arrhythmia and mortality in patients on haemodialysis. Despite standard adequate haemodialysis, hyperkalaemia is common in patients with end-stage renal disease (ESRD) at interdialytic intervals. Data on hyperkalaemia burden and its effects on dialysis patterns and serum potassium (sK) fluctuations in patients on haemodialysis in China remain limited. The prospective, observational cohort study (PRECEDE-K; NCT04799067) investiga ...[more]

PMID: 37559023

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Project description:IntroductionHyperkalaemia (HK) is a potentially life-threatening electrolyte imbalance associated with several adverse clinical outcomes and is common in patients with kidney failure. However, there is no evidence on the occurrence, recurrence and treatment of HK in patients on haemodialysis (HD) in China.Methods and analysisThe HK Prevalence, Recurrence, and Treatment in Haemodialysis Study is a prospective, multicentre, observational, cohort study being conducted across 15-18 sites in China. Approximately 600 patients with end-stage kidney disease on HD are anticipated to be enrolled and will be followed up for 24 weeks. Patients will be in the long interdialytic interval (LIDI) at enrolment and will receive follow-up care every 4 weeks in LIDI for pre-dialysis and post-dialysis (at enrolment only) serum potassium measurements. To obtain pre-dialysis serum potassium levels in the short interdialytic interval (SIDI), a follow-up visit will be performed in the SIDI during the first week. Information on concomitant medications, blood gas analysis and biochemistry measurements will be obtained at enrolment and at each follow-up visit. The primary endpoint will be the proportion of patients experiencing HK (defined as serum potassium level >5.0 mmol/L) at the study enrolment or during the 24-week follow-up. The key secondary endpoint will be the proportion of patients experiencing HK recurrence (defined as any HK event after the first HK event) within 1-6 months (if applicable) during the 24-week follow-up, including enrolment assessment.Ethics and disseminationThis study has been approved by Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (2020-040). Other participating subcentres must also obtain ethics committee approval prior to the start of the study. The Good Clinical Practice regulations shall be strictly followed during the test implementation. Amendments to the protocol will be reviewed by the ethics committees. Written informed consent will be obtained from all participants before collection of any patient data and patient information. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberClinicalTrials.gov Registry (NCT04799067).

Project description:PurposeThe global burden of kidney failure is increasing, but the treatment of kidney failure varies widely between patients, between dialysis facilities and over time. The Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D) aims to conduct efficient and timely cohort studies on associations between those variations and clinical and patient-reported outcomes.ParticipantsIncluded are outpatients aged 20 years old or older who are undergoing haemodialysis and have consented to participate. A total of 2895 patients were enrolled from 25 facilities in Japan between August 2018 and July 2020 and are to be followed until 31 December 2026. Chart review and annual questionnaires are used to collect data on patient characteristics and on outcomes including quality of life. Data on medications, haemodialysis prescriptions and blood tests are obtained from existing electronic records. Data are collected retrospectively from 1 January 2017 to patient enrolment, and prospectively from patient enrolment until the end of December 2026.Findings to dateTo date, the mean age is 68.3 (SD 12.2) years and 35.2% are female. The most common cause of kidney failure is diabetic nephropathy (37.4%). In January 2020, the facilities' median weekly doses of erythropoietin stimulating agent (ESA) and of intravenous vitamin D ranged from 1846 to 9692 IU (epoetin alfa equivalent) and 0.78 to 2.25 µg (calcitriol equivalent), respectively. The facilities' percentages of patients to whom calcimimetics are prescribed varied from 19% to 79%. During the retrospective period (averaging 1.85 years per participant), the incidence rates of any hospitalisation and of hospitalisation due to cardiovascular disease were 67.2 and 12.0 per 100 person-years, respectively.Future plansAQuAH-D data will be updated every 6 months and will be available for studies addressing a wide range of research questions, using the advantages of granular data and quality-of-life measurement of ageing patients on haemodialysis.

Project description:ObjectivesHyperkalaemia is a potentially life-threatening disorder in patients undergoing haemodialysis (HD). Excess mortality and hospitalisation have been associated with hyperkalaemia (HK) after the long (2-day) interdialytic interval (LIDI) in patients on thrice a week HD compared with the short (1-day) interdialytic interval. Moreover, not much research has been conducted in China on the descriptive epidemiology and management of HK among different HD centres. The aim of this study is to address this evidence gap by investigating the risk factors associated with HK clinical burden at the HD facility level, current HD centres management patterns, serum potassium management patterns, as well as the risk factors associated with crude mortality in China.DesignMulticentre, observational, retrospective cohort study.SettingThis study plans to enrol 300 HD centres across China. Haemodialysis centres having ≥100 patients on maintenance HD within 3 years before study initiation, with participation willingness, routine blood collection post-LIDI and death records will be included.ParticipantsPatients aged ≥18 years and on chronic HD for ≥3 months will be considered eligible. Summary data about serum potassium, characteristics of patients, facility practice patterns will be collected at HD facility level and death records will be at the patient level.Primary and secondary outcome measuresThe primary outcome will be to examine the association between suspected risk factors and HK prevalence at HD facility level. Suspected risk factors include dialysis prescriptions and serum potassium testing frequency, characteristics of patients and related medication usage. The secondary outcome will be to determine the HK prevalence, serum potassium management pattern and risk factors associated with crude mortality. The primary and secondary outcomes will be analysed using regression models. Exploratory outcomes will further investigate the risk factors associated with serum potassium ≥6.0 and ≥6.5 mmol/L.ConclusionThe study is expected to provide insights to improve dialysis practice patterns and understand the clinical burden of HK.Ethics and disseminationThis study protocol was reviewed and approved by the Institutional Review Boards and Ethics Committee of Peking University People's Hospital (Approval number: 2020PHB324-01). The results will be disseminated through national and international presentations and peer-reviewed publications.Trial registration numberNCT05020717.

Project description:BackgroundPolypharmacy is a significant clinical issue for patients on dialysis but has been incompletely studied. We investigated the prevalence and costs of polypharmacy in a population-based cohort of participants treated with haemodialysis (HD) or peritoneal dialysis (PD).MethodsWe studied adults ≥20 years of age in Alberta, Canada receiving maintenance HD or PD as of 31 March 2019. We characterized participants as users of 0-29 drug categories of interest and those ≥65 years of age as users/non-users of potentially inappropriate medications (PIMs). We calculated the number of drug categories, daily pill burden, total annual cost and annual cost per participant and compared this to an age- and sex-matched cohort from the general Alberta population.ResultsAmong 2248 participants (mean age 63 years; 39% female) on HD (n = 1781) or PD (n = 467), the median number of prescribed drug categories was 6 [interquartile range (IQR) 4-8] and the median daily pill burden was 8.0 (IQR 4.6-12.6), with 5% prescribed ≥21.7 pills/day and 16.5% prescribed ≥15 pills/day. Twelve percent were prescribed at least one drug that is contraindicated in kidney failure. The median annual per-participant cost was ${\$}$3831, totalling ≈${\$}$11.6 million annually for all participants. When restricting to the 1063 participants ≥65 years of age, the median number of PIM categories was 2 (IQR 1-2), with a median PIM pill burden of 1.2 pills/day (IQR 0.5-2.4). Compared with PD participants, HD participants had a similar daily pill burden, higher use of PIMs and higher annual per-participant cost. Pill burden and associated costs for participants on dialysis were >3-fold and 10-fold higher, respectively, compared with the matched participants from the general population.ConclusionParticipants on dialysis have markedly higher use of prescription medications and associated costs than the general population. Effective methods to de-prescribe in the dialysis population are needed.

Project description:BackgroundPatients undergoing haemodialysis (HD) are often discouraged from eating fruits and vegetables because of fears of hyperkalaemia and undernutrition, yet evidence to support these claims is scarce. We here explore the association between adherence to a healthy plant-based diet with serum potassium, surrogates of nutritional status and attainment of energy/protein intake targets in HD patients.MethodsWe performed an observational single-centre study of stable patients undergoing HD with repeated dietary assessment every 3 months. Patients were provided with personalized nutritional counselling according to current guidelines. The diet was evaluated by 3-day food records and characterized by a healthy plant-based diet score (HPDS), which scores positively the intake of plant foods and negatively animal foods and sugar. The malnutrition inflammation score (MIS) and serum potassium were also assessed at each visit. We used mixed-effects models to evaluate the association of the HPDS with markers of nutritional status, serum potassium levels and attainment of energy/protein intake targets.ResultsAfter applying inclusion and exclusion criteria, a total of 150 patients contributing to 470 trimestral observations were included. Their mean age was 42 years [standard deviation (SD) 18] and 59% were women. In multivariable models, a higher HPDS was not associated with serum potassium levels or odds of hyperkalaemia {potassium >5.5 mEq/L; odds ratio [OR] 1.00 [95% confidence interval (CI) 0.94-1.07] per HPDS unit higher}. Patients with a higher HPDS did not differ in terms of energy intake [OR for consuming <30 kcal/kg day 1.05 (95% CI 0.97-1.13)] but were at risk of low protein intake [OR for consuming <1.1 g of protein/kg/day 1.11 (95% CI 1.04-1.19)]. A higher HPDS was associated with a lower MIS, indicating better nutritional status.ConclusionsIn patients undergoing HD, adherence to a healthy plant-based diet was not associated with serum potassium, hyperkalaemia or differences in energy intake. Although these patients were less likely to reach daily protein intake targets, they appeared to associate with better nutritional status over time.

Dataset Information

Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K).

Background

Methods

Results

Conclusions

Trial registration

Publications

Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K).

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