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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Proof of Concept Clinical Study of CTI-01 in Patients Undergoing Major Cardiac Surgery With Cardiopulmonary Bypass

Conditions
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Coronary Disease, Heart Valve Diseases

Intervention / Treatment
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* Drug: CTI-01 (ethyl pyruvate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CTI-01 (ethyl pyruvate)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  |  | 
| Composite morbidity endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory dysfunction |  |  | 
| Cardiac dysfunction |  |  | 
| Renal dysfunction |  |  | 
| Gastrointestinal dysfunction |  |  | 
| Mental status |  |  | 
| Length of ICU (Intensive Care Unit)/hospital stay |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass grafting, Heart valve prosthesis implantation, Cardiopulmonary bypass, Oxidative stress, Inflammation, Endotoxemia