CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
March 15, 2006 updated by: Critical Therapeutics
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Laguna Hills, California, United States, 92653
- Saddleback Memorial Medical Center
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Los Angeles, California, United States, 90033
- University of Southern California
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San Francisco, California, United States, 94115
- Kaiser Permanente
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Kansas
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Wichita, Kansas, United States, 67208
- Research Support Personnel
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Maryland
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Salisbury, Maryland, United States, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
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New York
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New York, New York, United States, 10016
- NYU Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Greenville, North Carolina, United States, 27834
- East Carolina University - Brody School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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West Chester, Pennsylvania, United States, 19380
- Chester County Hospital - The Cardiovasular Center
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Texas
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Houston, Texas, United States, 77030
- St. Luke's Episcopal Hospital/Texas Heart Institute
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Washington
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Tacoma, Washington, United States, 98405
- MultiCare Health System
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Wisconsin
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Milwaukee, Wisconsin, United States, 53295
- Medical College of Wisconsin - VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Death
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Composite morbidity endpoint
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Secondary Outcome Measures
Outcome Measure |
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Respiratory dysfunction
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Cardiac dysfunction
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Renal dysfunction
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Gastrointestinal dysfunction
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Mental status
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Length of ICU (Intensive Care Unit)/hospital stay
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Walter Newman, Ph.D., Critical Therapeutics Incorporated
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Parsonnet V, Dean D, Bernstein AD. A method of uniform stratification of risk for evaluating the results of surgery in acquired adult heart disease. Circulation. 1989 Jun;79(6 Pt 2):I3-12. Erratum In: Circulation 1990 Sep;82(3):1078.
- Bennett-Guerrero E, Ayuso L, Hamilton-Davies C, White WD, Barclay GR, Smith PK, King SA, Muhlbaier LH, Newman MF, Mythen MG. Relationship of preoperative antiendotoxin core antibodies and adverse outcomes following cardiac surgery. JAMA. 1997 Feb 26;277(8):646-50.
- Ulloa L, Ochani M, Yang H, Tanovic M, Halperin D, Yang R, Czura CJ, Fink MP, Tracey KJ. Ethyl pyruvate prevents lethality in mice with established lethal sepsis and systemic inflammation. Proc Natl Acad Sci U S A. 2002 Sep 17;99(19):12351-6. doi: 10.1073/pnas.192222999. Epub 2002 Sep 3.
- Woo YJ, Taylor MD, Cohen JE, Jayasankar V, Bish LT, Burdick J, Pirolli TJ, Berry MF, Hsu V, Grand T. Ethyl pyruvate preserves cardiac function and attenuates oxidative injury after prolonged myocardial ischemia. J Thorac Cardiovasc Surg. 2004 May;127(5):1262-9. doi: 10.1016/j.jtcvs.2003.11.032.
- Fink MP. Ethyl pyruvate: a novel anti-inflammatory agent. Crit Care Med. 2003 Jan;31(1 Suppl):S51-6. doi: 10.1097/00003246-200301001-00008.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
April 6, 2005
First Submitted That Met QC Criteria
April 6, 2005
First Posted (Estimate)
April 7, 2005
Study Record Updates
Last Update Posted (Estimate)
March 17, 2006
Last Update Submitted That Met QC Criteria
March 15, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTI-01-C04-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.