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Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass (COMPACT)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
ACE/ARB continuation
ACE/ARB withdrawal
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Coronary artery bypass grafting, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, Surgical valve repair, Valve Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery
  • On an ACE or ARB for a minimum of 7 days

Exclusion Criteria:

  • Emergency surgery
  • Pre-operative shock (defined as systolic blood pressure < 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device)
  • Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents)
  • ACE or ARB therapy < 7 days
  • Any mineralocorticoid receptor antagonist therapy.

Sites / Locations

  • University of Alberta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ACE/ARB Continuation

ACE/ARB withdrawal

Arm Description

ACE/ARB will be continued up to and including the morning of surgery.

ACE/ARB will be discontinued medication 48 hours prior to surgery

Outcomes

Primary Outcome Measures

Adherence to the study protocol
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Feasibility of study enrollment
>50% of eligible patients are successfully enrolled in the trial
Feasibility of Study
>=95% completeness of outcomes

Secondary Outcome Measures

Feasibility of the Study
Reasons for non-recruitment
Incidence of post operative Shock
Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)
Duration of Shock
Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)
Vasopressors use
Number and maximum dose of vasopressors
Post operative intravenous anti-hypertensive use
The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)
Duration of intravenous vasodilator use
The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)
Vasodilator use
The number and maximum dose of vasodilators
Incidence of vasoplegic shock
Vasopressor administration for at lead 4 hours despite intravenous fluid administration
Pre-operative heart failure deterioration
Any increase in diuretic dose in 48 hours prior to surgery
Post-operative acute kidney injury
Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery
Change in renal function
Difference between baseline and peak post-operative creatinine
Initiation of renal replacement therapy
Peak post-operative troponin
Peak post-operative troponin within 72 hours of surgery
Stroke
Incidence of any stroke within 30 days of surgery
In hospital Mortality

Full Information

First Posted
March 17, 2014
Last Updated
March 20, 2018
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT02096406
Brief Title
Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass
Acronym
COMPACT
Official Title
COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronary artery disease is a leading cause of death, hospitalization, and health care costs in developed nations. Coronary revascularization with coronary artery bypass graft (CABG) surgery improves the long term survival in patients with diabetes and multi-vessel disease. Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce mortality and subsequent cardiac events in patients with coronary artery disease undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have suggested that pre-operative ACE administration is associated with an increased risk of post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies have failed to confirm these findings and further suggested ACE are associated with a reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal group required significantly fewer vasopressors during cardiopulmonary bypass but more intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs should be held or continued immediately prior to CABG surgery and a survey of cardiac surgeons suggests that current clinical practice is divided. This pilot study aims to establish the feasibility of the study design and to determine the frequency of clinical endpoints among patients who continue and discontinue ACE prior to cardiac surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Coronary artery bypass grafting, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, Surgical valve repair, Valve Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACE/ARB Continuation
Arm Type
Other
Arm Description
ACE/ARB will be continued up to and including the morning of surgery.
Arm Title
ACE/ARB withdrawal
Arm Type
Other
Arm Description
ACE/ARB will be discontinued medication 48 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
ACE/ARB continuation
Intervention Description
ACE/ARB will be taken the morning of surgery with a sip of water
Intervention Type
Drug
Intervention Name(s)
ACE/ARB withdrawal
Intervention Description
ACE/ARB will be stopped 48 hours prior to surgery
Primary Outcome Measure Information:
Title
Adherence to the study protocol
Description
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Time Frame
From randomization to surgery
Title
Feasibility of study enrollment
Description
>50% of eligible patients are successfully enrolled in the trial
Time Frame
30 dasys
Title
Feasibility of Study
Description
>=95% completeness of outcomes
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Feasibility of the Study
Description
Reasons for non-recruitment
Time Frame
30 days
Title
Incidence of post operative Shock
Description
Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)
Time Frame
3 hours
Title
Duration of Shock
Description
Post-operative shock (use of any intravenous vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, and/or methylene blue) and mechanical support devices (left ventricular assist devices, intra-aortic balloon pumps, or extracorporeal membrane oxygenation) initiated within the first 3 hours of CVICU admission)
Time Frame
7 days
Title
Vasopressors use
Description
Number and maximum dose of vasopressors
Time Frame
7 days
Title
Post operative intravenous anti-hypertensive use
Description
The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)
Time Frame
7 days
Title
Duration of intravenous vasodilator use
Description
The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)
Time Frame
7 days
Title
Vasodilator use
Description
The number and maximum dose of vasodilators
Time Frame
7 days
Title
Incidence of vasoplegic shock
Description
Vasopressor administration for at lead 4 hours despite intravenous fluid administration
Time Frame
4 hours
Title
Pre-operative heart failure deterioration
Description
Any increase in diuretic dose in 48 hours prior to surgery
Time Frame
48 hours
Title
Post-operative acute kidney injury
Description
Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery
Time Frame
7 days
Title
Change in renal function
Description
Difference between baseline and peak post-operative creatinine
Time Frame
7 days
Title
Initiation of renal replacement therapy
Time Frame
7 days
Title
Peak post-operative troponin
Description
Peak post-operative troponin within 72 hours of surgery
Time Frame
72 hours
Title
Stroke
Description
Incidence of any stroke within 30 days of surgery
Time Frame
30 days
Title
In hospital Mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other Pre-specified Outcome Measures:
Title
ACE or ARB use at hospital discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Duration of post-operative mechanical ventilation
Description
Time to extubation after admission to ICU
Time Frame
7 days
Title
Cardiovascular ICU length of stay
Time Frame
Participants will be followed for the duration of the ICU stay, an expected average of 2 days
Title
ICU readmission
Description
Incidence and cause of any ICU readmission after discharge to lower acuity ward post-operatively.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery On an ACE or ARB for a minimum of 7 days Exclusion Criteria: Emergency surgery Pre-operative shock (defined as systolic blood pressure < 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device) Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents) ACE or ARB therapy < 7 days Any mineralocorticoid receptor antagonist therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean van Diepen, MD, Msc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30371293
Citation
van Diepen S, Norris CM, Zheng Y, Nagendran J, Graham MM, Gaete Ortega D, Townsend DR, Ezekowitz JA, Bagshaw SM. Comparison of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Management Strategies Before Cardiac Surgery: A Pilot Randomized Controlled Registry Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009917. doi: 10.1161/JAHA.118.009917.
Results Reference
derived

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Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass

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