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Completed

NCT Number: NCT02096406

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACE/ARB continuation

Drug

ACE/ARB will be taken the morning of surgery with a sip of water

ACE/ARB withdrawal

Drug

ACE/ARB will be stopped 48 hours prior to surgery

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

COMParison of Angiotensin Converting Enzyme Inhibitor managemenT Strategies Prior to Coronary Artery Bypass Surgery (the COMPACT Trial): a Pilot Randomized Controlled Registry Study

Acronym: COMPACT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2014
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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