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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

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Heart Valve Diseases Drug: CTI-01 (ethyl pyruvate) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Primary Outcome Measures :
  1. Death
  2. Composite morbidity endpoint

Secondary Outcome Measures :
  1. Respiratory dysfunction
  2. Cardiac dysfunction
  3. Renal dysfunction
  4. Gastrointestinal dysfunction
  5. Mental status
  6. Length of ICU (Intensive Care Unit)/hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00107666

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United States, California
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
University of Southern California
Los Angeles, California, United States, 90033
Kaiser Permanente
San Francisco, California, United States, 94115
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Kansas
Research Support Personnel
Wichita, Kansas, United States, 67208
United States, Maryland
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New York
NYU Medical Center
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University - Brody School of Medicine
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Chester County Hospital - The Cardiovasular Center
West Chester, Pennsylvania, United States, 19380
United States, Texas
St. Luke's Episcopal Hospital/Texas Heart Institute
Houston, Texas, United States, 77030
United States, Washington
MultiCare Health System
Tacoma, Washington, United States, 98405
United States, Wisconsin
Medical College of Wisconsin - VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Critical Therapeutics
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Study Director: Walter Newman, Ph.D. Critical Therapeutics Incorporated

Layout table for additonal information Identifier: NCT00107666     History of Changes
Other Study ID Numbers: CTI-01-C04-201
First Posted: April 7, 2005    Key Record Dates
Last Update Posted: March 17, 2006
Last Verified: March 2006
Keywords provided by Critical Therapeutics:
Coronary artery bypass grafting
Heart valve prosthesis implantation
Cardiopulmonary bypass
Oxidative stress
Additional relevant MeSH terms:
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Coronary Disease
Heart Valve Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases