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Completed

NCT Number: NCT01091961

Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications

Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.

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Key information

Conditions

Hypertension Cardiovascular Diseases Heart Diseases Heart Failure Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • currently taking an ACEi, ARB or both
  • no change in these medications during the two weeks prior to study enrollment
  • scheduled for non-cardiac surgery requiring regional or general anesthesia
  • minimum overnight anticipated length of stay
  • age ≥18 years.

Exclusion criteria

  • explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
  • significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
  • significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg)
  • prior enrollment in the study
  • participation in another research study of antihypertensive medications

Treatment and study plan

Preoperative ACEi/ARB management

Procedure

Patients will either hold their chronic ACEi/ARB medication for at least 24 hours prior to surgery, or continue to take the ACEi/ARB medication up to and including the day of surgery

Primary outcomes

  1. Mean arterial blood pressure

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Clinically significant hypotension

    Time frame: 30 days after surgery

  2. Clinically significant hypertension

    Time frame: 30 days after surgery

  3. All-cause mortality

    Time frame: 30 days after surgery

  4. Cardiovascular morbidity

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Pre-Operative Inhibition of the Angiotensin System Study: A Prospective Randomized Single-Blinded Trial of Pre-Operative Management of Medications That Inhibit the Renin-Angiotensin System

Acronym: PASS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2010
Registry last updated
Oct 28, 2021

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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