Official Title: “Randomized Controlled 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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Study Primary Completion Date: February 2006

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • furosemide
• Placebo Comparator: 2
  • placebo

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• 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
    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
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Calgary

Overall Clinical Trial Officials and Contacts

Norman RC Campbell, MD Principal Investigator University of Calgary, Calgary, Alberta, Canada  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00115726

Study ID Number: 15326

ClinicalTrials.gov Identifier: NCT00115726

Health Authority: Canada: Health Canada