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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.
 
ClinicalTrials.gov Identifier: NCT00107666
Recruitment Status : Terminated
First Posted : April 7, 2005
Last Update Posted : March 17, 2006
Sponsor:
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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00107666


Locations
Show Show 17 study locations
Sponsors and Collaborators
Critical Therapeutics
Investigators
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Study Director: Walter Newman, Ph.D. Critical Therapeutics Incorporated
Publications:
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ClinicalTrials.gov Identifier: NCT00107666    
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
Inflammation
Endotoxemia
Additional relevant MeSH terms:
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Coronary Disease
Heart Valve Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases