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Trial record 60 of 243 for:    furosemide

Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115726
Recruitment Status : Completed
First Posted : June 24, 2005
Last Update Posted : February 22, 2008
The Centre for the Advancement of Health
Information provided by:
University of Calgary

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.

Condition or disease Intervention/treatment Phase
Hypertension Hypotension Edema Congestive Heart Failure Drug: furosemide Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Study Start Date : September 2000
Actual Primary Completion Date : February 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: 1
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)

Placebo Comparator: 2
Drug: placebo
patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. (2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death. [ Time Frame: hospital stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115726

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United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T6R 1R4
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5C1
Sponsors and Collaborators
University of Calgary
The Centre for the Advancement of Health
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Principal Investigator: Norman RC Campbell, MD University of Calgary, Calgary, Alberta, Canada

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Responsible Party: Dr. Nadia Khan, University of Calgary Identifier: NCT00115726     History of Changes
Other Study ID Numbers: 15326
First Posted: June 24, 2005    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: February 2008
Keywords provided by University of Calgary:
blood pressure
peripheral edema
congestive heart failure
Additional relevant MeSH terms:
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Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action