Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
NCT ID: NCT00990795
Last Updated: 2010-11-02
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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TERMINATED
PHASE1
72 participants
INTERVENTIONAL
2010-04-30
2010-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Cyclosporine
Cyclosporine Group: 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.
cyclosporine
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.
Placebo
Placebo: 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.
saline 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.
Interventions
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cyclosporine
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.
saline 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.
Eligibility Criteria
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Inclusion Criteria
* Patients with multi-vessel coronary artery disease
* Patients undergoing isolated valvular heart surgery (aortic/ mitral)
* Patients undergoing CABG
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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University of Texas Medical School Houston
Principal Investigators
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Jon-Cecil M Walkes, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical School Houston
Heinrich Taegtmeyer, MD
Role: STUDY_DIRECTOR
University of Texas Medical School Houston
George K Goodrick, PhD
Role: STUDY_CHAIR
University of Texas Medical School Houston
Locations
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University of Texas Medical School Houston
Houston, Texas, United States
Countries
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Other Identifiers
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CYCLO1
Identifier Type: -
Identifier Source: org_study_id