CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Status:
Terminated
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
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.