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Insulin Cardioplegia for Poor Left Ventricular Function

Insulin Cardioplegia Trial for Poor Left Ventricular Function

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00188994
Enrollment
800
Registered
2005-09-16
Start date
1999-08-31
Completion date
Unknown
Last updated
2005-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Dysfunction

Keywords

Myocardial Protection, Myocardial Metabolism, Ventricular Function, Cardiovascular Disease, Cardioplegic Additives

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%).

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%.

Interventions

DRUGInsulin Cardioplegia

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Low Output Syndrome

Secondary

MeasureTime frame
Total Troponin I Release

Countries

Canada

Contacts

Primary ContactChet Jabier-Nacario, BScN
chet.nacario@uhn.on.ca416-340-4800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026