CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
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
1 other identifier
interventional
150
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 6, 2005
CompletedFirst Posted
Study publicly available on registry
April 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedMarch 17, 2006
March 1, 2006
April 6, 2005
March 15, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Death
Composite morbidity endpoint
Secondary Outcomes (6)
Respiratory dysfunction
Cardiac dysfunction
Renal dysfunction
Gastrointestinal dysfunction
Mental status
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
University of Southern California
Los Angeles, California, 90033, United States
Kaiser Permanente
San Francisco, California, 94115, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Research Support Personnel
Wichita, Kansas, 67208, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
NYU Medical Center
New York, New York, 10016, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University - Brody School of Medicine
Greenville, North Carolina, 27834, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Chester County Hospital - The Cardiovasular Center
West Chester, Pennsylvania, 19380, United States
St. Luke's Episcopal Hospital/Texas Heart Institute
Houston, Texas, 77030, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
Medical College of Wisconsin - VA Medical Center
Milwaukee, Wisconsin, 53295, United States
Related Publications (5)
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.
PMID: 2720942BACKGROUNDBennett-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.
PMID: 9039883BACKGROUNDUlloa 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.
PMID: 12209006BACKGROUNDWoo 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.
PMID: 15115981BACKGROUNDFink MP. Ethyl pyruvate: a novel anti-inflammatory agent. Crit Care Med. 2003 Jan;31(1 Suppl):S51-6. doi: 10.1097/00003246-200301001-00008.
PMID: 12544977BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Walter Newman, Ph.D.
Critical Therapeutics Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 6, 2005
First Posted
April 7, 2005
Study Start
April 1, 2005
Study Completion
April 1, 2006
Last Updated
March 17, 2006
Record last verified: 2006-03