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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Procedure: Preoperative ACEi/ARB management

• Registration Number: NCT01091961
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holding ACEi/ARB	Preoperative ACEi/ARB management	Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery.
Continuing ACEi/ARB	Preoperative ACEi/ARB management	Patients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery.

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Clinically significant hypertension	30 days after surgery
Clinically significant hypotension	30 days after surgery
All-cause mortality	30 days after surgery
Cardiovascular morbidity	30 days after surgery

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada