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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
ACE/ARB will be taken the morning of surgery with a sip of water
ACE/ARB will be stopped 48 hours prior to surgery
University of Alberta Hospital
Edmonton, Alberta, Canada
Adherence to the study protocol
Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized
Time frame: From randomization to surgery
Feasibility of study enrollment
\>50% of eligible patients are successfully enrolled in the trial
Time frame: 30 dasys
Feasibility of Study
\>=95% completeness of outcomes
Time frame: 60 days
Feasibility of the Study
Reasons for non-recruitment
Time frame: 30 days
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)
Time frame: 3 hours
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)
Time frame: 7 days
Vasopressors use
Number and maximum dose of vasopressors
Time frame: 7 days
Post operative intravenous anti-hypertensive use
The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)
Time frame: 7 days
Duration of intravenous vasodilator use
The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)
Time frame: 7 days
Vasodilator use
The number and maximum dose of vasodilators
Time frame: 7 days
Incidence of vasoplegic shock
Vasopressor administration for at lead 4 hours despite intravenous fluid administration
Time frame: 4 hours
Pre-operative heart failure deterioration
Any increase in diuretic dose in 48 hours prior to surgery
Time frame: 48 hours
Post-operative acute kidney injury
Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery
Time frame: 7 days
Change in renal function
Difference between baseline and peak post-operative creatinine
Time frame: 7 days
Initiation of renal replacement therapy
Time frame: 7 days
Peak post-operative troponin
Peak post-operative troponin within 72 hours of surgery
Time frame: 72 hours
Stroke
Incidence of any stroke within 30 days of surgery
Time frame: 30 days
In hospital Mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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