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

NCT ID: NCT00107666

Last Updated: 2006-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Disease Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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CTI-01 (ethyl pyruvate)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Critical Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Walter Newman, Ph.D.

Role: STUDY_DIRECTOR

Critical Therapeutics Incorporated

Locations

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Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Kaiser Permanente

San Francisco, California, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Research Support Personnel

Wichita, Kansas, United States

Site Status

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

NYU Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

East Carolina University - Brody School of Medicine

Greenville, North Carolina, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Chester County Hospital - The Cardiovasular Center

West Chester, Pennsylvania, United States

Site Status

St. Luke's Episcopal Hospital/Texas Heart Institute

Houston, Texas, United States

Site Status

MultiCare Health System

Tacoma, Washington, United States

Site Status

Medical College of Wisconsin - VA Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 2720942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9039883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12209006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15115981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12544977 (View on PubMed)

Other Identifiers

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CTI-01-C04-201

Identifier Type: -

Identifier Source: org_study_id