Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial
| Autor: | David Wellsted, Ken Farrington, Bassam Alchi, Enric Vilar, James O. Burton, Andrew Davenport, Sivakumar Sridharan, Raja Mohammed Kaja Kamal |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Renal function end stage renal failure Kidney law.invention Cognition Randomized controlled trial Renal Dialysis law medicine Humans Multicenter Studies as Topic Medical prescription Dialysis Randomized Controlled Trials as Topic Protocol (science) Renal Medicine business.industry Months time Montreal Cognitive Assessment General Medicine adult nephrology Rating score United Kingdom Emergency medicine dialysis Feasibility Studies Kidney Failure Chronic Medicine business |
| Zdroj: | BMJ Open, Vol 10, Iss 8 (2020) BMJ Open |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2019-035919 |
| Popis: | IntroductionPreserving residual kidney function (RKF) may be beneficial to patients on haemodialysis (HD) and it has been proposed that commencing dialysis incrementally rather than three times a week may preserve RKF. In Incremental HD, target dose includes a contribution from RKF, which is added to HD dose, allowing individualisation of the HD prescription. We will conduct a feasibility randomised controlled trial (RCT) comparing incremental HD and conventional three times weekly treatments in incident HD patients. The study is designed also to provide pilot data to allow determination of effect size to power a definitive study.Methods and analysisAfter screening to ensure native renal urea clearance >3 mL/min/1.73 m2, the study will randomise 54 patients within 3 months of HD initiation to conventional in-centre thrice weekly dialysis or incremental in-centre HD commencing 2 days a week. Subjects will be followed up for 12 months. The study will be carried out across four UK renal centres.The primary outcome is to evaluate the feasibility of conducting a definitive RCT and to estimate the difference in rate of decline of RKF between the two groups at 6 and 12 months time points. Secondary outcomes will include the impact of dialysis intensity on vascular access events, major adverse cardiac events and survival. Impact of dialysis intensity on patient-reported outcomes measures, cognition and frailty will be assessed using EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score. Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.This study will inform the design of a definitive study, adequately powered to determine whether RKF is better preserved after incremental HD initiation compared with conventional initiation.Ethics and disseminationEthics approval has been granted by Cambridge South Research Ethics Committee, United Kingdom(REC17/EE/0311). Results will be disseminated via peer-reviewed publication.Trial registration numberNCT03418181 |
| Databáze: | OpenAIRE |
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