Insulin Cardioplegia for Poor Left Ventricular Function
NCT ID: NCT00188994
Last Updated: 2005-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
800 participants
INTERVENTIONAL
1999-08-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Insulin Cardioplegia
Eligibility Criteria
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Inclusion Criteria
* LV grade 3 or 4, LVEF \<40% by angio, echo, RNA.
Exclusion Criteria
* 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.
0 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University Health Network, Toronto
OTHER
Principal Investigators
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Terrence M. Yau
Role: PRINCIPAL_INVESTIGATOR
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)
Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Chet Jabier-Nacario, BScN
Role: primary
References
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1. Yau,TM, Fedak PWM, Weisel RD, Teng C, Ivanov J. Predictors of operative risk for coronary bypass operations in patients with left ventricular dysfunction. J Thorac Cardiovasc Surg 1999; 118:1006-1013. 2. RaoV, Ivanov J, Weisel RD, Ikonomidis JS, Christakis GT, David TE. Predictors of low cardiac output syndrome after coronary artery bypass. J Thorac Cardiovasc Surg 1996; 112:38-51. 3. Yau TM, Weisel RD, Mickle DAG, et al: Optimal delivery of blood cardioplegia. Circulation 1991; 84 (SAuppl II):II-380-388. 4. Yau TM, Weisel RD, Mickle DAG, et al: Alternative techniques of cardioplegia. Circulation 1992; 86(Suppl II):II-377-384. 5. Yau TM, Ikonomidis JS, Weisel RD, et al: Which techniques of cardioplegia prevent ischemia? Ann Thorac Surg 1993; 56:1020-1028. 6. Yau TM, Ikonomiodis JS, Weisel RD, et al: Ventricular function after normothermic versus hypothermic cardioplegia. J Thorac Cardiovasc Surg 1993; 105:883-844. 7. Rao V, Merante F, Weisel RD, Shirai T, Ikonomidis JS, Cohen G, Tumiati LC, Shiono N, Li RK, Mickle DAG, Robinson BH. Insulin stimulates pyruvate dehydrogenase and protects human ventricular cardiomyocytes from simulated ischemia. J Thorac Cardiovasc 1998; 116:485-94. 8. Rao V, Borger MA, Weisel RD, Ivanov J, Christakis GT, Cohen G, Yau TM,. Insulin cardioplegia for elective coronary bypass surgery. J Thorac Cardiovasc Surg 2000; 119: 1176-1184. 9. Yau TM, Mickle DAG, Weisel RD: Myocardial free radical reperfusion injury during cardiac surgery, in Kron IL, Mavroudis C (eds): Frontiers in cardiovascular surgical research: State of Art Reviews: Cardiac Surgery. Hanley & Belfus, 1990; 703-712. 10. Christakis GT, Weisel RD, Fremes SE, Ivanov J, David TE, Goldman BS, Salerno TA and the Cardiovascular Surgeons of the University of Toronto, Coronary Artery bypass grafting in patients with poor ventricular function. J Thorac Cardiovasc Surg 1992; 103:1083-1092.
Other Identifiers
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CIHR Grant No. HSF NA4189
Identifier Type: -
Identifier Source: secondary_id
98-E089
Identifier Type: -
Identifier Source: org_study_id