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

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

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

16 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
Death
Composite morbidity endpoint

Secondary Outcome Measures

Outcome Measure
Respiratory dysfunction
Cardiac dysfunction
Renal dysfunction
Gastrointestinal dysfunction
Mental status
Length of ICU (Intensive Care Unit)/hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Critical Therapeutics

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

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.

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