1.
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.
2.
Supervised oral protein supplementation during dialysis in patients with elevated C-reactive protein levels: a two phase, longitudinal, single center, open labeled study.
Beddhu, S, Filipowicz, R, Chen, X, Neilson, JL, Wei, G, Huang, Y, Greene, T
BMC nephrology. 2015;:87
Abstract
BACKGROUND Inflammation is considered one of the major causes of protein-energy wasting in maintenance hemodialysis (MHD) patients. It is unclear whether dietary interventions can impact nutritional status and quality of life in MHD patients with elevated C-reactive protein (CRP) levels. Therefore, we examined the hypothesis that supervised intra-dialysis protein supplementation in MHD patients with elevated plasma CRP will improve protein stores and quality of life. METHODS A 24 week, two phase, longitudinal, single center, open labeled study of 50 MHD patients with plasma CRP > 3 mg/L was conducted. During the 12-week observation phase dietary advice was provided to increase protein intake to 1.2 g/kg/day. In the 12-week treatment phase 45 g of liquid protein supplement was provided at each dialysis treatment. Protein nitrogen appearance (PNA), mid-arm muscle circumference (MAMC), serum albumin, body mass index (BMI) and quality of life (assessed by Short Form-12 questionnaire) were measured at baseline, 12 and 24 weeks. RESULTS Median plasma CRP at baseline was 16.0 (IQR 7.7 to 25.1) mg/L. The mean MAMC was 26.5 ± 3.9 cm, BMI 29.2 ± 6.9 kg/m(2) and plasma albumin 3.8 ± 0.3 g/dl. During the intervention period, mean PNA increased by 0.13 g/kg/d (p = 0.01) under a mixed effects model. However, there were no clinically or statistically significant effects on MAMC (p = 0.87), plasma albumin (p = 0.70), BMI (p = 0.09), physical (p = 0.32) or mental (p = 0.96) composite scores. CONCLUSIONS In MHD patients with elevated plasma CRP but otherwise mostly normal nutritional parameters, intra-dialytic oral protein supplement was effective in increasing protein intake but did not provide a detectable impact on nutritional status or quality of life.