Efficacy and safety of furosemide for prevention of intradialytic hypotension in haemodialysis patients: protocol for a multicentre randomised controlled trial.
BMJ Open
; 11(7): e048015, 2021 07 05.
Article
in En
| MEDLINE
| ID: mdl-34226226
ABSTRACT
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 ANDANALYSIS:
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 11 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.Key words
Full text:
1
Collection:
01-internacional
Health context:
1_ASSA2030
/
2_ODS3
/
6_ODS3_enfermedades_notrasmisibles
Database:
MEDLINE
Main subject:
Furosemide
/
Hypotension
Type of study:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Observational_studies
Aspects:
Ethics
Limits:
Humans
Country/Region as subject:
Asia
Language:
En
Journal:
BMJ Open
Year:
2021
Document type:
Article