NCT00115726

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_4 hypertension

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

February 22, 2008

Status Verified

February 1, 2008

Enrollment Period

5.4 years

First QC Date

June 23, 2005

Last Update Submit

February 20, 2008

Conditions

HypertensionHypotensionEdemaCongestive Heart Failure

Keywords

anesthesiahypotensionfurosemideblood pressureperipheral edemadiureticsurgerycongestive heart failure

Outcome Measures

Primary Outcomes (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).

    hospital stay

Secondary Outcomes (2)

  • Patients will be followed up for the duration of their hospital stay for the following endpoints: (1) Development of congestive heart failure exacerbation

    hospital stay

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

    hospital stay

Study Arms (2)

1

EXPERIMENTAL

furosemide

Drug: furosemide

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

furosemideDRUG

for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)

1
placeboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Foothills Hospital

Calgary, Alberta, T6R 1R4, Canada

Location

University of Western Ontario

London, Ontario, N6A 5C1, Canada

Location

MeSH Terms

Conditions

HypertensionHypotensionEdemaHeart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Norman RC Campbell, MD

    University of Calgary, Calgary, Alberta, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2005

First Posted

June 24, 2005

Study Start

September 1, 2000

Primary Completion

February 1, 2006

Study Completion

April 1, 2007

Last Updated

February 22, 2008

Record last verified: 2008-02

Locations

CA(2)US(1)