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	Phase IV

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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.
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00115726

Nadia A Khan, MD      604 266 0961    nakhan@shaw.ca
William Ghali, MD      403 210 9317    wghali@ucalgary.ca

Ohio
      The Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Canada, Alberta
      Foothills Hospital, Calgary,  Alberta,  T6R 1R4,  Canada; Recruiting
Canada, Ontario
      University of Western Ontario, London,  Ontario,  N6A 5C1,  Canada; No longer recruiting

Study chairs or principal investigators

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

Study ID Numbers:  15326; 15326
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 23, 2005
ClinicalTrials.gov Identifier:  NCT00115726
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-07-05