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

NCT01091961 | Completed

• 2 other identifiers: R-09-48716503
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean arterial blood pressure

  24 hours after surgery

Secondary Outcomes (4)

• 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

Study Arms (2)

Continuing ACEi/ARB

ACTIVE COMPARATOR

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

Holding ACEi/ARB

ACTIVE COMPARATOR

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

Procedure: Preoperative ACEi/ARB management

Interventions

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

Continuing ACEi/ARB; Holding ACEi/ARB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Hypertension; Hypotension; Heart Failure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Marko Mrkobrada, MD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 24, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

CA (1)