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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01091961
First received: March 22, 2010
Last updated: March 23, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Hypertension
Procedure: Preoperative ACEi/ARB management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Mean arterial blood pressure [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinically significant hypotension [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Clinically significant hypertension [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Cardiovascular morbidity [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuing ACEi/ARB
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
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
Active Comparator: Holding ACEi/ARB
Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery.
Procedure: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091961

Contacts
Contact: Marko Mrkobrada, MD (519) 663-3170 mmrkobrada@gmail.com
Contact: George Dresser, MD, PhD (519) 663-3342 george.dresser@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Marko Mrkobrada, MD    (519) 663-3170    mmrkobrada@gmail.com   
Principal Investigator: Marko Mrkobrada, MD         
Sub-Investigator: Brian Larocque, MD         
Sub-Investigator: Neal Badner, MD         
Sub-Investigator: George Dresser, MD, PhD         
Sub-Investigator: Craig Railton, MD, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Marko Mrkobrada, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Marko Mrkobrada/Principal Investigator, University of Western Ontario
ClinicalTrials.gov Identifier: NCT01091961     History of Changes
Other Study ID Numbers: R-09-487, 16503
Study First Received: March 22, 2010
Last Updated: March 23, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Angiotensin Receptor Antagonists
Angiotensin II Type 1 Receptor Blockers
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014