Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
The purpose of this study is to determine whether continuing or discontinuing furosemide (a diuretic) on the day of elective noncardiac surgery for those who take furosemide on a chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery. Our hypothesis is that the usual practice of continuing furosemide on the day of surgery would contribute to more hypotension during surgery than discontinuing furosemide.
Congestive Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure|
- Proportion of patients developing hypotension during the operative period. Hypotension is defined based on blood pressure criteria (systolic BP <90 mmHg or 35% drop in mean arterial pressure) (or vasopressor treatment during surgery). [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
- Patients will be followed up for the duration of their hospital stay for the following endpoints: (1) Development of congestive heart failure exacerbation [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
- (2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death. [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2000|
|Study Completion Date:||April 2007|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)
Placebo Comparator: 2
patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.
A significant proportion of patients who undergo surgery take medications on a chronic basis. Little is known about the effects of these medications on the successful conduct of anesthesia and surgery. Diuretics like furosemide may contribute to low blood pressure during surgery, an outcome associated with cardiovascular complications. However, many patients are recommended to take their diuretics on the day of surgery. We wished to determine if preoperative administration of furosemide contributes to intraoperative hypotension compared to placebo.
Comparison: We conducted a randomized, double blind placebo controlled trial to compare the effect of furosemide with that of placebo on intraoperative hypotension using intraoperative blood pressure recordings in patients who take furosemide chronically and were undergoing noncardiac surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115726
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Calgary, Alberta, Canada, T6R 1R4|
|University of Western Ontario|
|London, Ontario, Canada, N6A 5C1|
|Principal Investigator:||Norman RC Campbell, MD||University of Calgary, Calgary, Alberta, Canada|