Clinical trial NCT00115726: Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Official title: Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Hypotension
Edema
Congestive Heart Failure
Keywords: anesthesia
hypotension
furosemide
blood pressure
peripheral edema
diuretic
surgery
congestive heart failure
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: The Centre for the Advancement of Health
First posted: 2005-06-24
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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).
timeFrame: hospital stay
Secondary outcomes:
measure: Patients will be followed up for the duration of their hospital stay for the following endpoints: (1) Development of congestive heart failure exacerbation
timeFrame: hospital stay
measure: (2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death.
timeFrame: hospital stay
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: University of Calgary, Calgary, Alberta, Canada
name: Norman RC Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: