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

NCT ID: NCT01091961

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

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.

Detailed Description

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Conditions

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Hypertension

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Continuing ACEi/ARB

Patients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery.

Group Type ACTIVE_COMPARATOR

Preoperative ACEi/ARB management

Intervention Type 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

Holding ACEi/ARB

Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery.

Group Type ACTIVE_COMPARATOR

Preoperative ACEi/ARB management

Intervention Type 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

Interventions

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Preoperative ACEi/ARB management

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marko Mrkobrada, MD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16503

Identifier Type: OTHER

Identifier Source: secondary_id

R-09-487

Identifier Type: -

Identifier Source: org_study_id