Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure - Full Text View

Sponsor:	University of Calgary
Collaborator:	The Centre for the Advancement of Health
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00115726

Purpose

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 Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

Resource links provided by NLM:

MedlinePlus related topics: Edema Heart Failure High Blood Pressure Low Blood Pressure

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment:	198
Study Start Date:	September 2000
Study Completion Date:	April 2007
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 furosemide	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 placebo	Drug: placebo patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115726

Locations

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

Investigators

Principal Investigator:

Norman RC Campbell, MD

University of Calgary, Calgary, Alberta, Canada

More Information

No publications provided

Responsible Party:	Dr. Nadia Khan, University of Calgary
ClinicalTrials.gov Identifier:	NCT00115726 History of Changes
Other Study ID Numbers:	15326, 15326
Study First Received:	June 23, 2005
Last Updated:	February 20, 2008
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

anesthesia
hypotension
furosemide
blood pressure

peripheral edema
diuretic
surgery
congestive heart failure

Additional relevant MeSH terms:

Edema
Heart Failure
Hypertension
Hypotension
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Furosemide

Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012