Abstract
BackgroundPreserved residual kidney function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes.Methods/Design516 pateints commencing haemodialysis, aged >18 with RKF of > 3 ml/min/1.73 m2 or a urine volume >500 ml per day or per the shorter inter-dialytic period will be consented and enrolled into a pragmatic, open-label, randomized controlled trial. The intervention is incorporation of bioimpedance spectroscopy (BI) determination of normally hydrated weight to set a post-dialysis target weight that limits volume depletion, compared to current standard practice. Clinicians and participants will be blinded to BI measures in the control group and a standardized record capturing management of fluid status will be used in all participants. Primary outcome is preservation of residual kidney function assessed as time to anuria (≤100 ml/day or ≤200 ml urine volume in the short inter-dialytic period). A sample size of 516 was based upon a cumulative incidence of 30% anuria in the control group and 20% in the treatment group and 11% competing risks (death, transplantation) over 10 months, with up to 2 years follow-up.Secondary outcomes include rate of decline in small solute clearance, significant adverse events, hospitalization, loss of vascular access, cardiovascular events and interventions, dialysis efficacy and safety, dialysis-related symptoms and quality of life. Economic evaluation will be carried out to determine the cost-effectiveness of the intervention. Analyses will be adjusted for patient characteristics and dialysis unit practice patterns relevant to fluid management.DiscussionThis trial will establish the added value of undertaking BI measures to support clinical management of fluid status and establish the relationship between fluid status and preservation of residual kidney function in incident haemodialysis patients.Trial registrationISCCTN Number: 11342007, completed 26/04/2016; NIHR Portfolio number: CPMS31766; Sponsor: Keele University
Highlights
Preserved residual kidney function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients
The Canada USA study (CANUSA) study found that each 250 ml of urine per day increased 2-year survival by 36% in peritoneal dialysis patients [1] and in the Netherlands cooperative study of adequacy in dialysis (NECOSAD) study complete anuria in haemodialysis (HD) patients increased the relative risk of death 17-fold compared to those with well-preserved kidney function [2]
Our recent survey of fluid management practice patterns in UK units indicates that this is still being pursued in the majority of units [11], despite the risk it poses to residual kidney function by setting in place a continuing vicious cycle of volume depletion, excessive thirst and high inter-dialytic fluid gains
Summary
Adoption of new technologies to support clinical management requires scrutiny no less than the introduction of new pharmacological interventions. To try and understand this better for BISTRO we have developed a template that will both help clinicians order their approach to fluid assessment and clarify why they chose to over-ride the BI-derived normally hydrated weight The disadvantage of this approach may be that fluid management is ‘improved’ in the control group, so putting the intervention under greater pressure to demonstrate a benefit; the advantage is a better understanding of the intervention and even if the study is negative we will have, for the first time, a validated template to support fluid management. We have endeavoured to minimize this risk by separating the BI measurements from the clinical assessments and blinding both clinicians and participants to the BI measures in the control group This will be a major focus of the training sessions that will be undertaken at all the sites, which will ensure consistency in how the intervention is implemented.
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
