Coronary DiseasePhase 2NCT00107666
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
A Phase 2 study testing CTI-01 (ethyl pyruvate) in people with Coronary Disease and Heart Valve Diseases, run by Critical Therapeutics at 17 sites in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Heart Valve Diseases
- What is being tested?
- CTI-01 (ethyl pyruvate)
- How many people
- 150 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
East Carolina University - Brody School of Medicine
Greenville, North Carolina, 27834
St. Luke's Episcopal Hospital/Texas Heart Institute
Houston, Texas, 77030
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
University of Southern California
Los Angeles, California, 90033
Medical College of Wisconsin - VA Medical Center
Milwaukee, Wisconsin, 53295
NYU Medical Center
New York, New York, 10016
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
Kaiser Permanente
San Francisco, California, 94115
Baystate Medical Center
Springfield, Massachusetts, 01199
MultiCare Health System
Tacoma, Washington, 98405
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Chester County Hospital - The Cardiovasular Center
West Chester, Pennsylvania, 19380
Research Support Personnel
Wichita, Kansas, 67208
About this study
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
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.
- Conditions
- Coronary Disease, Heart Valve Diseases
- Being tested
- CTI-01 (ethyl pyruvate)
- Keywords
- Coronary artery bypass grafting, Heart valve prosthesis implantation, Cardiopulmonary bypass, Oxidative stress, Inflammation, Endotoxemia
- Medical subject headings
- Coronary Disease, Heart Valve Diseases, Inflammation, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTI-01 (ethyl pyruvate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Composite morbidity endpoint
Secondary outcomes (6)
Respiratory dysfunction
Cardiac dysfunction
Renal dysfunction
Gastrointestinal dysfunction
Mental status
Length of ICU (Intensive Care Unit)/hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2005 (estimated)
- Study startApr 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Critical Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Walter Newman, Ph.D., Study director, Critical Therapeutics Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107666
- Sponsor's protocol ID
- CTI-01-C04-201
- Status last verified
- Mar 2006
- First submitted
- 6 Apr 2005
- Last updated
- 17 Mar 2006
- Results posted
- No
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.
PubMed 2720942Bennett-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.
PubMed 9039883Ulloa 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.
PubMed 12209006Woo 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.
PubMed 15115981Fink MP. Ethyl pyruvate: a novel anti-inflammatory agent. Crit Care Med. 2003 Jan;31(1 Suppl):S51-6. doi: 10.1097/00003246-200301001-00008.
PubMed 12544977
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00107666
- Acronym / sponsor ID
- CTI-01-C04-201
- Conditions
- Coronary Disease, Heart Valve Diseases
- Keywords
- Coronary artery bypass grafting, Heart valve prosthesis implantation, Cardiopulmonary bypass, Oxidative stress, Inflammation, Endotoxemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants
- Lead sponsor
- Critical TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Apr 2006
- First posted
- 7 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- Emergency cardiac surgery
- Significant concomitant surgery
- Minimally invasive or thoracic surgical approach
- Preoperative mechanical assist device
- Body weight <50 kg or >140 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTI-01 (ethyl pyruvate) | Drug | – |
Primary outcome
Death
Composite morbidity endpoint
6 secondary outcomes
Respiratory dysfunction
Cardiac dysfunction
Renal dysfunction
Gastrointestinal dysfunction
Mental status
Length of ICU (Intensive Care Unit)/hospital stay
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2006.
- Background: PubMed 2720942Parsonnet 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.
- Background: PubMed 9039883Bennett-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.
- Background: PubMed 12209006Ulloa 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.
- Background: PubMed 15115981Woo 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.
- Background: PubMed 12544977Fink MP. Ethyl pyruvate: a novel anti-inflammatory agent. Crit Care Med. 2003 Jan;31(1 Suppl):S51-6. doi: 10.1097/00003246-200301001-00008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Newman, Ph.D. study director
Critical Therapeutics Incorporated
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTI-01 (ethyl pyruvate) in people with Coronary Disease and Heart Valve Diseases, run by Critical Therapeutics at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00107666, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2006.