Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Hypotension Edema Congestive Heart Failure |
Drug: furosemide Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 198 |
| Study Start Date: | September 2000 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
furosemide
|
Drug: furosemide
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
placebo
|
Drug: placebo
patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All adults referred to preoperative assessment clinics by surgeons for elective non-cardiac surgery who routinely take furosemide.
- Participants must also be able to give informed consent
Exclusion Criteria:
- Less than 18 years of age
- Have comorbid conditions with which brief periods of hypotension may be particularly harmful such as: 1) pregnancy; 2) baseline hypotension (systolic <100 mmHg at the preoperative assessment clinic); 3) autonomic dysfunction; 4) severe aortic stenosis.
- Patients who take furosemide only on an 'as needed basis' rather than 'regularly'.
- Those patients who take less than 10 mg of furosemide daily
- Those patients who are undergoing local anesthetic only surgical procedures
- Patients who are unwilling or unable to give informed consent.
Contacts and Locations| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Canada, Alberta | |
| Foothills Hospital | |
| Calgary, Alberta, Canada, T6R 1R4 | |
| Canada, Ontario | |
| University of Western Ontario | |
| London, Ontario, Canada, N6A 5C1 | |
| Principal Investigator: | Norman RC Campbell, MD | University of Calgary, Calgary, Alberta, Canada |
More Information
No publications provided
| Responsible Party: | Dr. Nadia Khan, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00115726 History of Changes |
| Other Study ID Numbers: | 15326, 15326 |
| Study First Received: | June 23, 2005 |
| Last Updated: | February 20, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
anesthesia hypotension furosemide blood pressure |
peripheral edema diuretic surgery congestive heart failure |
Additional relevant MeSH terms:
|
Edema Heart Failure Hypertension Hypotension Signs and Symptoms Heart Diseases Cardiovascular Diseases Vascular Diseases Furosemide |
Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013