Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: ACE/ARB withdrawalDrug: ACE/ARB continuation
- Registration Number
- NCT02096406
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACE/ARB withdrawal ACE/ARB withdrawal ACE/ARB will be discontinued medication 48 hours prior to surgery ACE/ARB Continuation ACE/ARB continuation ACE/ARB will be continued up to and including the morning of surgery.
- Primary Outcome Measures
Name Time Method Adherence to the study protocol From randomization to surgery Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Feasibility of study enrollment 30 dasys \>50% of eligible patients are successfully enrolled in the trial
Feasibility of Study 60 days \>=95% completeness of outcomes
- Secondary Outcome Measures
Name Time Method Vasodilator use 7 days The number and maximum dose of vasodilators
Incidence of post operative Shock 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)
Duration of Shock 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)
Post operative intravenous anti-hypertensive use 7 days The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)
Feasibility of the Study 30 days Reasons for non-recruitment
Change in renal function 7 days Difference between baseline and peak post-operative creatinine
Stroke 30 days Incidence of any stroke within 30 days of surgery
Duration of intravenous vasodilator use 7 days The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)
Vasopressors use 7 days Number and maximum dose of vasopressors
Incidence of vasoplegic shock 4 hours Vasopressor administration for at lead 4 hours despite intravenous fluid administration
Pre-operative heart failure deterioration 48 hours Any increase in diuretic dose in 48 hours prior to surgery
Post-operative acute kidney injury 7 days Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery
Initiation of renal replacement therapy 7 days Peak post-operative troponin 72 hours Peak post-operative troponin within 72 hours of surgery
In hospital Mortality Participants will be followed for the duration of hospital stay, an expected average of 7 days
Trial Locations
- Locations (1)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada