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

N/ACompletedNCT01091961

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Hypertension

Interventions

Preoperative ACEi/ARB managementPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

Mean arterial blood pressure

Time frame: 24 hours after surgery

Secondary Outcomes

Clinically significant hypotension

Time frame: 30 days after surgery

Clinically significant hypertension

Time frame: 30 days after surgery

All-cause mortality

Time frame: 30 days after surgery

Cardiovascular morbidity

Time frame: 30 days after surgery

Data from ClinicalTrials.gov

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