Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-09 @ 5:58 PM
Study NCT ID:
NCT00107666
Status:
TERMINATED
Last Update Posted:
2006-03-17
First Post:
2005-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D019446', 'term': 'Endotoxemia'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046522', 'term': 'ethyl pyruvate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-04'}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2006-03-15', 'studyFirstSubmitDate': '2005-04-06', 'studyFirstSubmitQcDate': '2005-04-06', 'lastUpdatePostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death'}, {'measure': 'Composite morbidity endpoint'}], 'secondaryOutcomes': [{'measure': 'Respiratory dysfunction'}, {'measure': 'Cardiac dysfunction'}, {'measure': 'Renal dysfunction'}, {'measure': 'Gastrointestinal dysfunction'}, {'measure': 'Mental status'}, {'measure': 'Length of ICU (Intensive Care Unit)/hospital stay'}]}, 'conditionsModule': {'keywords': ['Coronary artery bypass grafting', 'Heart valve prosthesis implantation', 'Cardiopulmonary bypass', 'Oxidative stress', 'Inflammation', 'Endotoxemia'], 'conditions': ['Coronary Disease', 'Heart Valve Diseases']}, 'referencesModule': {'references': [{'pmid': '2720942', 'type': 'BACKGROUND', 'citation': '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': '9039883', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12209006', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15115981', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12544977', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parsonnet additive risk score greater than or equal to 15\n* Scheduled CABG (coronary artery bypass grafting) and/or cardiac valve repair or replacement surgery using cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Emergency cardiac surgery\n* Significant concomitant surgery\n* Minimally invasive or thoracic surgical approach\n* Preoperative mechanical assist device\n* Body weight \\<50 kg or \\>140 kg\n* Active systemic infection\n* Creatinine \\>3.0 mg/dL\n* History of hematologic or coagulation disorders\n* History of malignancy (past year)or organ transplantation\n* Use of immunosuppressive drugs or current immunosuppressed condition'}, 'identificationModule': {'nctId': 'NCT00107666', 'briefTitle': 'CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Critical Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CTI-01-C04-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CTI-01 (ethyl pyruvate)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Memorial Medical Center', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Support Personnel', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21801', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Peninsula Regional Medical Center', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Methodist Hospital', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University - Brody School of Medicine', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19380', 'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Chester County Hospital - The Cardiovasular Center', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Hospital/Texas Heart Institute", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin - VA Medical Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Walter Newman, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Critical Therapeutics Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Critical Therapeutics', 'class': 'INDUSTRY'}}}}