Insulin Cardioplegia for Poor Left Ventricular Function

University Health Network, Toronto800 enrolled

Overview

The purpose of this investigation is to develop a means to improve the recovery of cardiac metabolism and ventricular function following coronary artery bypass surgery (CABG) in patients with poor preoperative ventricular function (e.g. ejection fraction \<40%).

Hypothesis Insulin added to blood cardioplegia will improve the results of Coronary Artery Bypass Graft by reducing the incidence of low output syndrome (i.e., the requirement for inotropic or balloon pump assistance) in patients with a preoperative ejection fraction \<40%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

800

Conditions

Left Ventricular Dysfunction

Interventions

Insulin CardioplegiaDRUG

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has been referred for isolated coronary bypass surgery. * LV grade 3 or 4, LVEF \<40% by angio, echo, RNA. Exclusion Criteria: * Patient is undergoing reoperative surgery (i.e., has had any previous cardiac surgery) * Surgeon has planned another procedure in addition to coronary bypass surgery (e.g., valve repair, replacement, ascending aorta repair or replacement, left ventricular aneurysm resection, repair of congenital defect, carotid surgery, repair of abdominal aortic aneurysm). * Patient is scheduled for minimally invasive surgery. * More recent assessment of LV function with LV grade 1 0r 2, LVEF\>40%. * 5 or 6 days post MI.

Locations (1)

University Health Network

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Low Output Syndrome

Secondary Outcomes

Total Troponin I Release

Central Contacts

Chet Jabier-Nacario, BScN

CONTACT

416-340-4800 chet.nacario@uhn.on.ca

Data from ClinicalTrials.gov

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