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The efficacy and safety of low dialysate sodium levels for patients with maintenance haemodialysis: A systematic review and meta-analysis.
Geng, X, Song, Y, Hou, B, Ma, Y, Wang, Y
International journal of surgery (London, England). 2020;:332-339
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Abstract
BACKGROUND & AIM: Fluid overload and hypertension frequently results in cardiovascular disease, which is one of the leading causes of death in dialysis patients. It is plausible that low dialysate [Na+] may decrease total body sodium content, thereby reducing fluid overload and hypertension, and ultimately reducing cardiovascular disease morbidity and mortality. This meta-analysis was designed to evaluate the efficacy and safety of using a low (<138 mM) dialysate [Na+] for maintenance haemodialysis (HD) patients. METHODS We searched the Cochrane Library, PubMed, EMBASE, Web of Science up to August 22, 2019. Randomised controlled trials (RCTs), both parallel and cross-over, of low (<138 mM) versus neutral (138-140 mM) or high (>140 mM) dialysate [Na+] for maintenance HD patients were included. Mean difference (MD), risk ratio (RR) and 95% confidence interval (CI) values were estimated to compare the outcomes. Two reviewers extracted data and assessed trial quality independently. All statistical analyses were performed using the standard statistical procedures of RevMan 5.2. RESULTS 12 Randomised controlled trials with 390 patients were included in this meta-analysis. Of these studies, three studies were parallel group, and the remaining nine were crossover. Compared to neutral or high dialysate [Na+], low dialysate [Na+] reduced dialysis mean arterial pressure (MAP) with a pooled MD of -3.38 mmHg (95% CI -4.57 to -2.19; P < 0.00001), reduced interdialytic weight gain with a pooled MD of -0.35 kg (95% CI -0.51 to -0.18; P < 0.0001), reduced predialysis serum [Na+] with a pooled MD of -2.62 mM (95% CI -3.59 to -1.66; P < 0.00001). In contrast, low dialysate [Na+] increased intradialytic hypotension events with a pooled RR of 1.54 (95% CI 1.16 to 2.05; P = 0.003), increased the incidence of intradialytic cramps with a pooled RR of 1.77 (95% CI 1.15 to 2.73; P = 0.01). However, no difference was found between lower and higher dialysate [Na+] in systolic blood pressure and diastolic blood pressure. CONCLUSIONS Though our pooled result indicated that low dialysate [Na+] reduced MAP, interdialytic weight gain and predialysis serum [Na+] significantly, it also indicated that low dialysate [Na+] could increase the incidence of intradialytic hypotension and intradialytic cramps events. Considering the contradiction in efficacy and safety of low dialysate [Na+] in our analysis, future larger and up-to-date definitive studies are needed to evaluate the medium to long-term effects of low sodium levels in dialysis fluid, and better inform clinical practice.
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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.
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A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design.
Liu, L, Long, G, Ren, J, Li, J, Xu, J, Lei, J, Li, M, Qiu, M, Yuan, P, Sun, W, et al
BMC nephrology. 2012;:120
Abstract
BACKGROUND Bioimpedance analysis (BIA) has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD) patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients' survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. METHODS This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM-Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. DISCUSSIONS Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis.