CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
- Conditions
- Heart Valve DiseasesCoronary Disease
- Registration Number
- NCT00107666
- Lead Sponsor
- Critical Therapeutics
- Brief Summary
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction. The incidence of complications may exceed 30%. It has been speculated that an exaggerated inflammatory response to surgical trauma and the CPB machine are likely causes for this morbidity. Factors predisposing organ dysfunction include tissue injury, endotoxemia, and oxidative stress. High risk patients can be identified preoperatively through the validated Parsonnet Additive Risk Score. CTI-01 has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. These findings support its clinical use in critical care medicine including cardiac surgery. Patients will receive a total of six doses, administered intravenously just prior to and after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
- Parsonnet additive risk score greater than or equal to 15
- Scheduled CABG (coronary artery bypass grafting) and/or cardiac valve repair or replacement surgery using cardiopulmonary bypass
- Emergency cardiac surgery
- Significant concomitant surgery
- Minimally invasive or thoracic surgical approach
- Preoperative mechanical assist device
- Body weight <50 kg or >140 kg
- Active systemic infection
- Creatinine >3.0 mg/dL
- History of hematologic or coagulation disorders
- History of malignancy (past year)or organ transplantation
- Use of immunosuppressive drugs or current immunosuppressed condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite morbidity endpoint Death
- Secondary Outcome Measures
Name Time Method Cardiac dysfunction Respiratory dysfunction Gastrointestinal dysfunction Renal dysfunction Mental status Length of ICU (Intensive Care Unit)/hospital stay
Trial Locations
- Locations (17)
Kaiser Permanente
🇺🇸San Francisco, California, United States
NYU Medical Center
🇺🇸New York, New York, United States
Saddleback Memorial Medical Center
🇺🇸Laguna Hills, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
East Carolina University - Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
St. Luke's Episcopal Hospital/Texas Heart Institute
🇺🇸Houston, Texas, United States
Research Support Personnel
🇺🇸Wichita, Kansas, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Chester County Hospital - The Cardiovasular Center
🇺🇸West Chester, Pennsylvania, United States
MultiCare Health System
🇺🇸Tacoma, Washington, United States
Medical College of Wisconsin - VA Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Florida
🇺🇸Gainesville, Florida, United States