1.
Impact of twice- or three-times-weekly maintenance hemodialysis on patient outcomes: A multicenter randomized trial.
Dai, L, Lu, C, Liu, J, Li, S, Jin, H, Chen, F, Xue, Z, Miao, C
Medicine. 2020;(20):e20202
-
-
Free full text
-
Abstract
AIM: Maintenance hemodialysis (MHD) frequency is associated with survival and complication rates. Achieving the optimal balance between healthcare, quality of life (QOL), and medical costs is challenging. We compared complications, inflammatory status, nutritional status, and QOL between patients with different MHD frequencies. MATERIAL AND METHODS This was a multicenter randomized trial of patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou. Patients were grouped according to their treatment schedule over 1 year: twice-weekly or 3-times-weekly. Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale) were assessed. RESULTS One hundred forty patients were included aged 29 to 68 years (mean age, 50.9 ± 4.3 years). There were no significant differences in infection, heart failure, or cerebral hemorrhage complications between the 2 groups (P = .664). Pre-dialysis hemoglobin, high-sensitivity C-reactive protein, serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05). After 1 year of MHD, both groups exhibited significant improvements in these parameters (all P < .05) with no significant differences between groups. Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy did not improve after treatment (all P > .05), although a difference in BUN was observed between the 2 groups (P < .001). QOL was superior in the twice-weekly group than in the 3-times-weekly group (all P < .05), except for social support, which was slightly better in the 3-times-weekly group than in the twice-weekly group. CONCLUSIONS Twice- and 3-times-weekly MHD resulted in comparable inflammatory and nutritional clinical outcomes and adverse events. QOL was better for the twice-weekly schedule. Even for patients with economic constraints, twice- or 3-times-weekly MHD should be selected with caution after consideration of BUN levels at baseline.
2.
Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial.
Chen, J, Liu, Y, Chen, X, Sun, X, Li, W, Yang, W, Li, P, Sun, X, Wang, D, Jiang, H, et al
BMJ open. 2019;(9):e023162
Abstract
INTRODUCTION Starting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE. METHODS AND ANALYSIS A total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12-24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications. ETHICS AND DISSEMINATION Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017-119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings. TRIAL REGISTRATION NUMBER ClinicalTrial.gov. Registry (NCT03385902); pre-results.
3.
Effects of monthly dose and regular dosing of intravenous active vitamin D use on mortality among patients undergoing hemodialysis.
St Peter, WL, Li, S, Liu, J, Gilbertson, DT, Arneson, TJ, Collins, AJ
Pharmacotherapy. 2009;(2):154-64
Abstract
STUDY OBJECTIVES To determine if apparent protective mortality benefits of intravenous active vitamin D in patients undergoing hemodialysis extend across all groups defined by dialysis duration; if higher monthly dose and dosing regularity are associated with reduced mortality; and if intravenous active vitamin D use is associated with reduced cardiovascular, infectious, and cancer-related mortality. STUDY DESIGN Retrospective cohort study. DATA SOURCE Centers for Medicare and Medicaid Services End-Stage Renal Disease database. PATIENTS A total of 193,830 patients undergoing hemodialysis during 1999-2000, of whom 94,208 (48.6%) were taking intravenous active vitamin D in the baseline period. MEASUREMENTS AND MAIN RESULTS Time-varying Cox proportional hazards models were used to assess the effects of monthly vitamin D dose and dosing regularity over 3-month intervals on risk of all-cause and cause-specific death, by dialysis duration groups (<1 yr, 1 to <3 yrs, 3 to <5 yrs, and >or=5 yrs from dialysis initiation). Models were adjusted for baseline characteristics, time-varying hospital days, monthly epoetin alfa dose, mean hemoglobin level, and urea reduction ratio in the 3-month intervals. Maximum follow-up time was 5.25 years. Adjusted all-cause mortality risk was reduced 7-17% among patients receiving vitamin D each month of the 3-month interval, with the highest reduction among patients with shorter dialysis duration. However, regular vitamin D dosing did not show consistent benefit across dialysis duration groups for cardiovascular, infectious, cancer, or other (all deaths not attributable to cardiovascular disease, infection, or cancer) mortality. CONCLUSION Mortality benefits of intravenous vitamin D cannot be easily explained by currently proposed biologic mechanisms. Randomized controlled trials are needed to show definitively whether intravenous vitamin D can reduce all-cause and cause-specific mortality in patients undergoing dialysis compared with placebo.