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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096406
• Other study ID #: Pro00042749
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2014
• Last updated: March 20, 2018
• Start date: April 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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 stopped 48 hours prior to surgery

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ACE or ARB use at hospital discharge		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other	Duration of post-operative mechanical ventilation	Time to extubation after admission to ICU	7 days
Other	Cardiovascular ICU length of stay		Participants will be followed for the duration of the ICU stay, an expected average of 2 days
Other	ICU readmission	Incidence and cause of any ICU readmission after discharge to lower acuity ward post-operatively.	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Primary	Adherence to the study protocol	Proportion of patients who adhere to ACE/ARB continuation or withdrawal as randomized	From randomization to surgery
Primary	Feasibility of study enrollment	>50% of eligible patients are successfully enrolled in the trial	30 dasys
Primary	Feasibility of Study	>=95% completeness of outcomes	60 days
Secondary	Feasibility of the Study	Reasons for non-recruitment	30 days
Secondary	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)	3 hours
Secondary	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)	7 days
Secondary	Vasopressors use	Number and maximum dose of vasopressors	7 days
Secondary	Post operative intravenous anti-hypertensive use	The post-operative use intravenous vasodilators (nitroglycerine or nitroprusside)	7 days
Secondary	Duration of intravenous vasodilator use	The post-operative duration intravenous vasodilators (nitroglycerine or nitroprusside)	7 days
Secondary	Vasodilator use	The number and maximum dose of vasodilators	7 days
Secondary	Incidence of vasoplegic shock	Vasopressor administration for at lead 4 hours despite intravenous fluid administration	4 hours
Secondary	Pre-operative heart failure deterioration	Any increase in diuretic dose in 48 hours prior to surgery	48 hours
Secondary	Post-operative acute kidney injury	Acute kidney injury defined as a doubling of serum creatinine within 7 days of surgery	7 days
Secondary	Change in renal function	Difference between baseline and peak post-operative creatinine	7 days
Secondary	Initiation of renal replacement therapy		7 days
Secondary	Peak post-operative troponin	Peak post-operative troponin within 72 hours of surgery	72 hours
Secondary	Stroke	Incidence of any stroke within 30 days of surgery	30 days
Secondary	In hospital Mortality		Participants will be followed for the duration of hospital stay, an expected average of 7 days