Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
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|ClinicalTrials.gov Identifier: NCT00115726|
Recruitment Status : Completed
First Posted : June 24, 2005
Last Update Posted : February 22, 2008
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Hypotension Edema Congestive Heart Failure||Drug: furosemide Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure|
|Study Start Date :||September 2000|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||April 2007|
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.
- 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 ]
- 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 ]
- (2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death. [ Time Frame: hospital stay ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|