Coronary Disease, Heart Valve Diseases
Conditions
Keywords
Coronary artery bypass grafting, Heart valve prosthesis implantation, Cardiopulmonary bypass, Oxidative stress, Inflammation, Endotoxemia
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.
Interventions
DRUGCTI-01 (ethyl pyruvate)
Sponsors
Critical Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death | — |
| Composite morbidity endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal dysfunction | — |
| Gastrointestinal dysfunction | — |
| Respiratory dysfunction | — |
| Length of ICU (Intensive Care Unit)/hospital stay | — |
| Mental status | — |
| Cardiac dysfunction | — |
Countries
United States
Outcome results
None listed