Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT00948194
Status:
TERMINATED
Last Update Posted:
2021-05-28
First Post:
2009-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}, {'id': 'D045462', 'term': 'Endothelium-Dependent Relaxing Factors'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014665', 'term': 'Vasodilator Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nick.naughton@cuanschutz.edu', 'phone': '303-724-0833', 'title': 'Nick Naughton', 'organization': 'University of Colorado Denver'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Nitric Oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics\n\nNitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine if Inhaled Nitric Oxide Has Beneficial Effects on Overall Outcome After Extended Criteria Donor (EDC) Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Nitric Oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics'}, {'id': 'OG001', 'title': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics\n\nNitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery'}], 'timeFrame': '3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data.'}, {'type': 'SECONDARY', 'title': 'To Construct a Plasma Metabolic/Protein Profile of I/R Injury in Transplanted Livers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Nitric Oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics'}, {'id': 'OG001', 'title': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics\n\nNitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery'}], 'timeFrame': '3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data.'}, {'type': 'SECONDARY', 'title': 'To Examine the Effects of Nitric Oxide on Protein Synthesis and Metabolism Following Extended Criteria Donor Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Nitric Oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics'}, {'id': 'OG001', 'title': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics\n\nNitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery'}], 'timeFrame': '3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Nitric Oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics'}, {'id': 'FG001', 'title': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics\n\nNitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Blood drawn using incorrect test tube; sample invalid', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Nitric Oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics'}, {'id': 'BG001', 'title': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics\n\nNitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Cirrhosis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hepatitis C', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'HCC', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Hepatoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Primary Sclerosing Cholangitis (PSC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Fatty Liver (NASH)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Metabolic Disease (METDIS) - Alpha-1-Antitrypsin Deficiency (A-1-A)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Bone mets', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Model for End-Stage Liver Disease Score', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '5.42', 'groupId': 'BG000'}, {'value': '27.14', 'spread': '3.64', 'groupId': 'BG001'}, {'value': '26.75', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.59', 'spread': '5.01', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '5.83', 'groupId': 'BG001'}, {'value': '26.89', 'spread': '5.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline characteristics data was not collected one participant whose sample was invalid.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'This study was terminated when the P.I. left the university.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2009-07-24', 'resultsFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-26', 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine if Inhaled Nitric Oxide Has Beneficial Effects on Overall Outcome After Extended Criteria Donor (EDC) Liver Transplantation', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'To Construct a Plasma Metabolic/Protein Profile of I/R Injury in Transplanted Livers', 'timeFrame': '3 years'}, {'measure': 'To Examine the Effects of Nitric Oxide on Protein Synthesis and Metabolism Following Extended Criteria Donor Liver Transplantation', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Extended Donor Criteria'], 'conditions': ['Liver Transplantation', 'Ischemia/Reperfusion Injury', 'Oxidative Injury']}, 'descriptionModule': {'briefSummary': 'In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following revascularization of the donor graft.\n\nIn reviewing the literature, no uniform extended criteria donor classification exists. The characteristics most associated with liver graft failure appear to be cold ischemia time greater than 10 hours, warm ischemia time greater than 40 minutes, donor age \\> 55 years of age, donor hospitalization \\> 5 days, a donation after cardiac death (DCD) graft, and a split graft. The researchers will exclude warm ischemia time as this is impossible to predict prior to the transplantation. Any donor meeting at least one of the other criteria will be classified as an EDC donor.\n\nHypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC liver transplantation\n\n* Suppression of oxidative injury will improve graft function postoperatively as measured by International Normalized Ratio (INR) bilirubin, transaminases, and duration of hospital stay.\n\nHypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on reduction in post-reperfusion oxidative injury as readily measured by the detectable changes in the protein and metabolic profiles in plasma of patients treated with inhaled-NO\n\n* Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products, lactate, and hepatic osmolytes) that are consistent with acute liver injury will be decreased in NO-treated recipients.\n* Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated with inhaled-NO\n* Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial peroxiredoxins isoforms and the number that are oxidized in NO-treated liver recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 69 years of age\n* moderate to severe liver disease (MELD score 22 to 30)\n* is receiving a extended donor criteria liver graft\n\nExclusion Criteria:\n\n* undergoing multi-organ transplant\n* 70 years or older\n* diagnosed with hepatocarcinoma\n* diagnosed with either hepatopulmonary syndrome or pulmonary hypertension\n* pregnant'}, 'identificationModule': {'nctId': 'NCT00948194', 'briefTitle': 'Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Investigation of the Effect of Nitric Oxide on Ischemic Reperfusion Injury During Extended Donor Criteria Liver Transplantation', 'orgStudyIdInfo': {'id': '09-0137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No nitric oxide', 'description': 'This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics'}, {'type': 'EXPERIMENTAL', 'label': 'Nitric Oxide', 'description': 'Will receive Nitric oxide and other standard inhaled anesthetics', 'interventionNames': ['Drug: Nitric Oxide']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'otherNames': ['INOmax'], 'description': 'Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery', 'armGroupLabels': ['Nitric Oxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Matthew J. Fiegel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}