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

This study has been terminated.
Sponsor:
Information provided by:
Critical Therapeutics
ClinicalTrials.gov Identifier:
NCT00107666
First received: April 6, 2005
Last updated: March 15, 2006
Last verified: March 2006

April 6, 2005
March 15, 2006
April 2005
Not Provided
  • Death
  • Composite morbidity endpoint
Same as current
Complete list of historical versions of study NCT00107666 on ClinicalTrials.gov 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
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
April 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107666
CTI-01-C04-201
Not Provided
Not Provided
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