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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00107666
Recruitment Status : Terminated
First Posted : April 7, 2005
Last Update Posted : March 17, 2006
Information provided by:
Critical Therapeutics

April 6, 2005
April 7, 2005
March 17, 2006
April 2005
Not Provided
  • Death
  • Composite morbidity endpoint
Same as current
Complete list of historical versions of study NCT00107666 on Archive Site
  • Respiratory dysfunction
  • Cardiac dysfunction
  • Renal dysfunction
  • Gastrointestinal dysfunction
  • Mental status
  • Length of ICU (Intensive Care Unit)/hospital stay
Same as current
Not Provided
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CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Coronary Disease
  • Heart Valve Diseases
Drug: CTI-01 (ethyl pyruvate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2006
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Critical Therapeutics
Not Provided
Study Director: Walter Newman, Ph.D. Critical Therapeutics Incorporated
Critical Therapeutics
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP