PT  - JOURNAL ARTICLE
AU  - Wenwen Chen
AU  - Fang Wang
AU  - Yuliang Zhao
AU  - Ling Zhang
AU  - Zhiwen Chen
AU  - Mingjin Dai
TI  - Efficacy and safety of furosemide for prevention of intradialytic hypotension in haemodialysis patients: protocol for a multicentre randomised controlled trial
AID  - 10.1136/bmjopen-2020-048015
DP  - 2021 Jul 01
TA  - BMJ Open
PG  - e048015
VI  - 11
IP  - 7
4099  - http://bmjopen.bmj.com/content/11/7/e048015.short
4100  - http://bmjopen.bmj.com/content/11/7/e048015.full
SO  - BMJ Open2021 Jul 01; 11
AB  - Introduction Intradialytic hypotension (IDH) is a frequent and serious complication of maintaining haemodialysis (HD) patients and associated with subsequent cardiovascular events and higher mortality. Furosemide is commonly used in non-dialysis chronic kidney disease patients and can effectively manage the volume and blood pressure. However, these agents are often discontinued on initiation of dialysis. Two large observational studies have demonstrated that furosemide can lower the rate of IDH episodes. However, there is still no randomised controlled trial (RCT) to investigate the efficacy and safety of furosemide for prevention of IDH in HD patients. The purpose of this study was to assess the efficacy of furosemide in reducing IDH in HD patients with residual renal function.Methods and analysis A two-arm, parallel, multicente RCT will be conducted at 12 hospitals in China. An estimated sample of 560 HD patients will be recruited. Eligible patients will be randomly assigned to treatment group (patients receive oral furosemide 80 mg/day; after a 2-week treatment, if their urine volume is less than 400 mL/day, the dose of furosemide is adjusted to 160 mg/day) and blank control group via a central randomisation system using 1:1 ratio. The primary outcome is the occurrence of IDH. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat, which includes all patients randomised, and per-protocol population, which includes eligible patients who adhere to the planned treatment and follow-ups.Ethics and dissemination The trial protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2019.385)Results will be presented at national and international conferences and published in peer-reviewed journals.Trial registration number ChiCTR2000039724.