CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)

Stopped early · Phase 2

Conditions studied: Coronary Disease, Heart Valve Diseases

In brief

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.

Key facts

Study ID

NCT00107666

Run by

Critical Therapeutics

People needed

150

Starts

2005-04-01

Expected to finish

2006-04-01

Last updated by the study team

2006-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• University of Southern California — Los Angeles, California, United States
• Kaiser Permanente — San Francisco, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Research Support Personnel — Wichita, Kansas, United States
• Peninsula Regional Medical Center — Salisbury, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• NYU Medical Center — New York, New York, 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
• Chester County Hospital - The Cardiovasular Center — West Chester, Pennsylvania, United States
• St. Luke's Episcopal Hospital/Texas Heart Institute — Houston, Texas, United States
• MultiCare Health System — Tacoma, Washington, United States
• Medical College of Wisconsin - VA Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.