Cardiac Surgical Procedures
Conditions
Keywords
open heart surgery, cyclosporine, myocardial protection
Brief summary
Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. The purpose of the proposed study is to conduct a randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery, or coronary artery bypass surgery. Specifically the investigators will evaluate the cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors will be treatment group and cyclosporine versus placebo.
Detailed description
The specific aim of this study is to perform a randomized controlled study to compare the effects of cyclosporine v. placebo on changes in myocardial functioning associated with open heart surgery for isolated valvular or coronary artery bypass procedures. The research question is: Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of: * Transthoracic ECHO (TTE) assessment of ejection fraction * Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR) * Length of stay * 30-d mortality * Angina Scale * SF-36 measure of quality of life * Measures associated with myocardial function: 1. Cardiac Index 2. Blood glucose level 3. Serum Troponin I level 4. Free Fatty Acid levels 5. Serum CPK-MB levels 6. Serum phosphoratase levels
Interventions
DRUGcyclosporine
Cyclosporine Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team.
DRUGsaline solution
Placebo Group: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, 18 years of age or older * Patients with multi-vessel coronary artery disease * Patients undergoing isolated valvular heart surgery (aortic/ mitral) * Patients undergoing CABG
Exclusion criteria
* Patients with cardiac arrest * Patients with ventricular fibrillation * Patients with cardiogenic shock * Patients requiring circulatory arrest * Patients with known hypersensitivity to cyclosporine * Patients with known renal failure or a GFR \<50 ml/min/1.732 * Patients with liver failure * Patients with uncontrolled hypertension * Women who are pregnant or who are of childbearing age and not on contraception * Patients with a serum bilirubin level greater than 3 mg/100 mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Stay (LOS) | postoperative to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fraction (TTE) | postoperative |
| Cardiac Index | postoperative |
| SVO2 | Postoperative |
| Systemic Vascular Resistance (SVR) | postoperative |
Countries
United States
Outcome results
None listed