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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
History of Changes
  Purpose

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 Intervention Phase
Coronary Disease
Heart Valve Diseases
 Drug: CTI-01 (ethyl pyruvate)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Critical Therapeutics:

Primary Outcome Measures:
  • Death
  • Composite morbidity endpoint

Secondary Outcome Measures:
  • Respiratory dysfunction
  • Cardiac dysfunction
  • Renal dysfunction
  • Gastrointestinal dysfunction
  • Mental status
  • Length of ICU (Intensive Care Unit)/hospital stay

Estimated Enrollment: 150
Study Start Date: April 2005
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107666

Locations
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
Investigators
Study Director: Walter Newman, Ph.D. Critical Therapeutics Incorporated
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00107666     History of Changes
Other Study ID Numbers: CTI-01-C04-201
Study First Received: April 6, 2005
Last Updated: March 15, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Critical Therapeutics:
Coronary artery bypass grafting
Heart valve prosthesis implantation
Cardiopulmonary bypass
 Oxidative stress
Inflammation
Endotoxemia

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Heart Valve Diseases
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 16, 2013