Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Information source: University of Calgary
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Hypotension; Edema; Congestive Heart Failure
Intervention: furosemide (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Calgary Official(s) and/or principal investigator(s):
Norman RC Campbell, MD, Principal Investigator, Affiliation: University of Calgary, Calgary, Alberta, Canada
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.
Clinical Details
Official title: Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: 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).
Secondary outcome: Patients will be followed up for the duration of their hospital stay for the following endpoints: (1) Development of congestive heart failure exacerbation(2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Foothills Hospital, Calgary, Alberta T6R 1R4, Canada
The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
University of Western Ontario, London, Ontario N6A 5C1, Canada
Additional Information
Starting date: September 2000
Ending date: April 2007
Last updated: February 20, 2008
|
