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NCT Number: NCT00115726

Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Foothills Hospital, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Furosemide

Drug

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

Drug

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

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).

    Time frame: hospital stay

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • The Centre for the Advancement of Health

Registry information

Official study title

Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

Important dates

Study start
2000
Primary completion
2006
Study completion
2007
First posted
Jun 24, 2005
Registry last updated
Feb 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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