Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

NCT ID: NCT00115726

Last Updated: 2008-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2007-04-30

Brief Summary

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.

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.

Conditions

Hypertension; Hypotension; Edema; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

furosemide

Group Type: EXPERIMENTAL

furosemide

Intervention Type: DRUG

for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)

2

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.

Interventions

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)

Intervention Type: DRUG

placebo

patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Centre for the Advancement of Health

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

University of Calgary

Principal Investigators

Norman RC Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary, Calgary, Alberta, Canada

Locations

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Foothills Hospital

Calgary, Alberta, Canada

University of Western Ontario

London, Ontario, Canada

Countries

United States; Canada

Other Identifiers

15326

Identifier Type: -

Identifier Source: secondary_id

15326

Identifier Type: -

Identifier Source: org_study_id