Insulin Cardioplegia for Poor Left Ventricular Function

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00188994

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

800

Enrollment

Location

Study Details

Study Description

Brief Summary

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%).

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Dysfunction	Drug: Insulin Cardioplegia	N/A

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Insulin Cardioplegia Trial for Poor Left Ventricular Function

Study Start Date :

Aug 1, 1999

Outcome Measures

Primary Outcome Measures

Low Output Syndrome []

Secondary Outcome Measures

Total Troponin I Release []

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator: Terrence M. Yau, 21st Century Cardiac Surgical Society, Council on Cardiovascular and Thoracic Surgery (American Heart Association), Canadian Cardiovascular Society, Royal College of Physicians and Surgeons, Institute of Medical Sciences (University of Toronto)