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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Procedure: Preoperative ACEi/ARB management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuing ACEi/ARB<br>Patients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery. | Procedure: Preoperative ACEi/ARB management<br>* 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<br>|
| Active Comparator: Holding ACEi/ARB<br>Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery. | Procedure: Preoperative ACEi/ARB management<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant hypotension |  | 30 days after surgery | 
| Clinically significant hypertension |  | 30 days after surgery | 
| All-cause mortality |  | 30 days after surgery | 
| Cardiovascular morbidity |  | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACE inhibitor, ARB, Non-cardiac surgery, Perioperative, Preoperative, Hypotension, Congestive heart failure, Hypertension, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Type 1 Receptor Blockers, Perioperative Care