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

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ClinicalTrials.gov Identifier: NCT02096406
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sean van Diepen, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: ACE/ARB continuation Drug: ACE/ARB withdrawal Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ACE/ARB Continuation
ACE/ARB will be continued up to and including the morning of surgery.
Drug: ACE/ARB continuation
ACE/ARB will be taken the morning of surgery with a sip of water

ACE/ARB withdrawal
ACE/ARB will be discontinued medication 48 hours prior to surgery
Drug: ACE/ARB withdrawal
ACE/ARB will be stopped 48 hours prior to surgery




Primary Outcome Measures :
  1. Adherence to the study protocol [ Time Frame: From randomization to surgery ]
    Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized

  2. Feasibility of study enrollment [ Time Frame: 30 dasys ]
    >50% of eligible patients are successfully enrolled in the trial

  3. Feasibility of Study [ Time Frame: 60 days ]
    >=95% completeness of outcomes


Secondary Outcome Measures :
  1. Feasibility of the Study [ Time Frame: 30 days ]
    Reasons for non-recruitment

  2. Incidence of post operative Shock [ Time Frame: 3 hours ]
    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)

  3. Duration of Shock [ Time Frame: 7 days ]
    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)

  4. Vasopressors use [ Time Frame: 7 days ]
    Number and maximum dose of vasopressors

  5. Post operative intravenous anti-hypertensive use [ Time Frame: 7 days ]
    The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)

  6. Duration of intravenous vasodilator use [ Time Frame: 7 days ]
    The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)

  7. Vasodilator use [ Time Frame: 7 days ]
    The number and maximum dose of vasodilators

  8. Incidence of vasoplegic shock [ Time Frame: 4 hours ]
    Vasopressor administration for at lead 4 hours despite intravenous fluid administration

  9. Pre-operative heart failure deterioration [ Time Frame: 48 hours ]
    Any increase in diuretic dose in 48 hours prior to surgery

  10. Post-operative acute kidney injury [ Time Frame: 7 days ]
    Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery

  11. Change in renal function [ Time Frame: 7 days ]
    Difference between baseline and peak post-operative creatinine

  12. Initiation of renal replacement therapy [ Time Frame: 7 days ]
  13. Peak post-operative troponin [ Time Frame: 72 hours ]
    Peak post-operative troponin within 72 hours of surgery

  14. Stroke [ Time Frame: 30 days ]
    Incidence of any stroke within 30 days of surgery

  15. In hospital Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]

Other Outcome Measures:
  1. 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 ]
  2. Duration of post-operative mechanical ventilation [ Time Frame: 7 days ]
    Time to extubation after admission to ICU

  3. Cardiovascular ICU length of stay [ Time Frame: Participants will be followed for the duration of the ICU stay, an expected average of 2 days ]
  4. ICU readmission [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    Incidence and cause of any ICU readmission after discharge to lower acuity ward post-operatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096406


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Sean van Diepen, MD, Msc University of Alberta
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sean van Diepen, Assistant Professor of Critical Care Medicine and Cardiology, University of Alberta
ClinicalTrials.gov Identifier: NCT02096406    
Other Study ID Numbers: Pro00042749
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sean van Diepen, University of Alberta:
Coronary artery disease
Coronary artery bypass grafting
angiotensin converting enzyme inhibitor
angiotensin receptor blocker
Surgical valve repair
Valve Replacement
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases