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Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

Primary Purpose

Hypertension, Hypotension, Edema

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
furosemide
placebo
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring anesthesia, hypotension, furosemide, blood pressure, peripheral edema, diuretic, surgery, congestive heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Cleveland Clinic Foundation
  • Foothills Hospital
  • University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

furosemide

placebo

Outcomes

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).

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
(2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death.

Full Information

First Posted
June 23, 2005
Last Updated
February 20, 2008
Sponsor
University of Calgary
Collaborators
The Centre for the Advancement of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00115726
Brief Title
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

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary
Collaborators
The Centre for the Advancement of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypotension, Edema, Congestive Heart Failure
Keywords
anesthesia, hypotension, furosemide, blood pressure, peripheral edema, diuretic, surgery, congestive heart failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
furosemide
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
furosemide
Intervention Description
for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
(2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death.
Time Frame
hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman RC Campbell, MD
Organizational Affiliation
University of Calgary, Calgary, Alberta, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T6R 1R4
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5C1
Country
Canada

12. IPD Sharing Statement

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Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

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