Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-03-09 @ 2:35 AM
Study NCT ID:
NCT02633358
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2015-12-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'my686chen@gmail.com', 'phone': '0952122027', 'title': 'Dr. Da-Long Chen, director of cardiac intensive care unit', 'organization': 'China Medical University Hospital, Taichung, Taiwan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Pregnancy, terminal and metastatic cancer, uncontrolled bleeding and family refuse inform consent had been excluded.'}}, 'adverseEventsModule': {'timeFrame': '90-day follow up', 'eventGroups': [{'id': 'EG000', 'title': 'Therapeutic Hypothermia', 'description': 'Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 32, 'seriousNumAffected': 57}, {'id': 'EG001', 'title': 'Non-Hypothermia', 'description': 'Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 34, 'seriousNumAffected': 44}], 'seriousEvents': [{'term': 'Severe cerebral disability', 'notes': 'Severe cerebral disability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coma or vegetative state', 'notes': 'Coma or vegetative state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain death', 'notes': 'Brain death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Rate - Number of Participants Alive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'OG001', 'title': 'Non-hypothermia', 'description': 'Control group for non-hypothermia.\n\nAnti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}], 'classes': [{'categories': [{'title': 'Survival', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Non-survival', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.82', 'pValueComment': 'P-value less than 0.05 means significant data', 'groupDescription': 'Therapeutic hypothermia group compare with control group', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Test method for proportional data', 'nonInferiorityComment': 'Therapeutic hypothermia need to have superiority in the survival rate after 90 days'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days after enrollment', 'description': 'Survival rate according to the number of participants alive in the 90 days after enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group'}, {'type': 'SECONDARY', 'title': 'Neurologic Outcome - Number of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'OG001', 'title': 'Non-hypothermia', 'description': 'Control group for non-hypothermia.\n\nAnti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}], 'classes': [{'categories': [{'title': 'Favorable neurologic outcome', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Poor neurologic outcome', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.98', 'pValueComment': 'P value less than 0.05 means significant date', 'groupDescription': 'Therapeutic hypothermia group compare with control group', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Test method for proportional data', 'nonInferiorityComment': 'Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days after enrollment', 'description': 'Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Interleukin-6 - the Plasma Level of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'OG001', 'title': 'Non-hypothermia', 'description': 'Control group for non-hypothermia.\n\nAnti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}], 'classes': [{'title': '6 hours after enrollment', 'categories': [{'measurements': [{'value': '2064.1', 'spread': '178.2', 'groupId': 'OG000'}, {'value': '2392.4', 'spread': '181.3', 'groupId': 'OG001'}]}]}, {'title': '24 hours after enrollment', 'categories': [{'measurements': [{'value': '914.5', 'spread': '187.8', 'groupId': 'OG000'}, {'value': '5125.0', 'spread': '592.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value less than 0.05 is statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'between 6 and 24 hours after enrollment.', 'description': 'IL-6 level change', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized divided to two groups including therapeutic hypothermia and non-hypothermia group'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'OG001', 'title': 'Non-hypothermia', 'description': 'Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}], 'classes': [{'title': '6 hours after enrollment', 'categories': [{'measurements': [{'value': '169.1', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '188.1', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': '24 hours after enrollment', 'categories': [{'measurements': [{'value': '207.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '319.7', 'spread': '24.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value less than 0.05 is statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'between 6 and 24 hours after enrollment', 'description': 'Interleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Interleukin-6 Receptor - the Plasma Level of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'OG001', 'title': 'Non-hypothermia', 'description': 'Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}], 'classes': [{'title': '6 hours after enrollment', 'categories': [{'measurements': [{'value': '40.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '24 hours after enrollment', 'categories': [{'measurements': [{'value': '37.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value less then 0.05 is statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'between 6 and 24 hours after enrollment', 'description': 'Check the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'FG001', 'title': 'Non-hypothermia', 'description': 'Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: 2015 Jan. to 2018 Apr. Types of location: Cardiac intensive care units, China Medical University Hospital, Taichung, Taiwan'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Therapeutic Hypothermia', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling\n\nTherapeutic hypothermia: Therapeutic hypothermia'}, {'id': 'BG001', 'title': 'Non-Hypothermia', 'description': 'Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling'}, {'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': '50', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese in Taiwan', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Total 141 patients involved in this study. 87 patients divided in the therapeutic hypothermia group and 54 patients divided in the control group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-25', 'size': 939857, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-10T01:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-28', 'studyFirstSubmitDate': '2015-12-08', 'resultsFirstSubmitDate': '2018-08-19', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-12', 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Interleukin-6 - the Plasma Level of Participants', 'timeFrame': 'between 6 and 24 hours after enrollment.', 'description': 'IL-6 level change'}, {'measure': 'Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants', 'timeFrame': 'between 6 and 24 hours after enrollment', 'description': 'Interleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling'}, {'measure': 'Soluble Interleukin-6 Receptor - the Plasma Level of Participants', 'timeFrame': 'between 6 and 24 hours after enrollment', 'description': 'Check the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment'}], 'primaryOutcomes': [{'measure': 'Survival Rate - Number of Participants Alive', 'timeFrame': '90 days after enrollment', 'description': 'Survival rate according to the number of participants alive in the 90 days after enrollment.'}], 'secondaryOutcomes': [{'measure': 'Neurologic Outcome - Number of Participants', 'timeFrame': '90 days after enrollment', 'description': 'Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute myocardial infarction, cardiogenic shock'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '26567101', 'type': 'BACKGROUND', 'citation': 'Schmitt KR, Tong G, Berger F. Mechanisms of hypothermia-induced cell protection in the brain. Mol Cell Pediatr. 2014 Dec;1(1):7. doi: 10.1186/s40348-014-0007-x. Epub 2014 Dec 1.'}, {'pmid': '26525271', 'type': 'BACKGROUND', 'citation': 'Bro-Jeppesen J, Kjaergaard J, Stammet P, Wise MP, Hovdenes J, Aneman A, Horn J, Devaux Y, Erlinge D, Gasche Y, Wanscher M, Cronberg T, Friberg H, Wetterslev J, Pellis T, Kuiper M, Nielsen N, Hassager C; TTM-Trial Investigators. Predictive value of interleukin-6 in post-cardiac arrest patients treated with targeted temperature management at 33 degrees C or 36 degrees C. Resuscitation. 2016 Jan;98:1-8. doi: 10.1016/j.resuscitation.2015.10.009. Epub 2015 Oct 23.'}, {'pmid': '26455248', 'type': 'BACKGROUND', 'citation': 'Forkmann M, Kolschmann S, Holzhauser L, Ibrahim K, Guenther M, Christoph M, Fuhrmann JT, Boscheri A, Schmeibetaer A, Strasser RH, Wunderlich C. Target temperature management of 33 degrees C exerts beneficial haemodynamic effects after out-of-hospital cardiac arrest. Acta Cardiol. 2015 Aug;70(4):451-9. doi: 10.1080/ac.70.4.3096893.'}, {'pmid': '26386374', 'type': 'BACKGROUND', 'citation': "Nobile L, Lamanna I, Fontana V, Donadello K, Dell'anna AM, Creteur J, Vincent JL, Pappalardo F, Taccone FS. Greater temperature variability is not associated with a worse neurological outcome after cardiac arrest. Resuscitation. 2015 Nov;96:268-74. doi: 10.1016/j.resuscitation.2015.09.004. Epub 2015 Sep 16."}, {'pmid': '25756419', 'type': 'BACKGROUND', 'citation': 'Bro-Jeppesen J, Kjaergaard J, Wanscher M, Nielsen N, Friberg H, Bjerre M, Hassager C. Systemic Inflammatory Response and Potential Prognostic Implications After Out-of-Hospital Cardiac Arrest: A Substudy of the Target Temperature Management Trial. Crit Care Med. 2015 Jun;43(6):1223-32. doi: 10.1097/CCM.0000000000000937.'}, {'pmid': '25800582', 'type': 'BACKGROUND', 'citation': 'Dankiewicz J, Nielsen N, Annborn M, Cronberg T, Erlinge D, Gasche Y, Hassager C, Kjaergaard J, Pellis T, Friberg H. Survival in patients without acute ST elevation after cardiac arrest and association with early coronary angiography: a post hoc analysis from the TTM trial. Intensive Care Med. 2015 May;41(5):856-64. doi: 10.1007/s00134-015-3735-z. Epub 2015 Mar 24.'}, {'pmid': '39312301', 'type': 'DERIVED', 'citation': 'Chen D, Lin Y, Ko P, Lin J, Huang C, Wang G, Chang KC. Effect of targeted temperature management on systemic inflammatory responses after out-of-hospital cardiac arrest: A prospective cohort study. Medicine (Baltimore). 2024 Sep 20;103(38):e39780. doi: 10.1097/MD.0000000000039780.'}, {'pmid': '38943710', 'type': 'DERIVED', 'citation': 'Chen DL, Chung CM, Wang GJ, Chang KC. Lactate-to-albumin ratio and cholesterol levels predict neurological outcome in cardiac arrest survivors. Am J Emerg Med. 2024 Sep;83:9-15. doi: 10.1016/j.ajem.2024.06.029. Epub 2024 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death.\n\nWhile therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate and well cerebral performance.', 'detailedDescription': 'Despite emergency coronary revascularization coupled with medical stabilization, intra-aortic balloon pump have significantly improved survival in patients with cardiogenic shock complicating acute myocardial infarction, mortality still remains excessively high, being actually about 30-50%. Future research should focus on new therapeutic strategies, aimed to further decrease mortality rate of these patients or improve possible hospitalization and prognosis.\n\nHeart pumping failure result in cardiogenic shock. Increased LA filling pressure result in acute pulmonary edema, hypoxemic respiratory failure, even congestive kidney and congestive liver. Decreased stroke volume result in hypoperfusion obviously direct induce acute renal failure, disturbance consciousness and lactate accumulation, even, shock liver. Multiple organ failure is the major mortality in the patients suffered from cardiogenic shock after acute myocardial infarction.\n\nCardiogenic shock remains the leading cause of death in patients hospitalized for myocardial infarction . Systemic inflammation , especially endovascular Interleukin-6, triggered by Tumor necrosis factor-alfa and Interleukin-1 beta result in inappropriate vasodilatation is observed in many patients with cardiogenic shock and may contribute to an excess mortality rate. In recent study, interleukin-6 represented a reliable independent early prognostic marker of 30-day mortality.\n\nTherapeutic hypothermia (34℃) increase stroke volume, reduce muscle oxygen consumption and enhance anti-inflammatory action . The mechanism of anti-inflammatory effect for therapeutic hypothermia in cardiogenic shock is still unclear, need to further study in clinical trial. Furthermore, this study will provide new strategy to increase survival rate in cardiogenic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-100 years\n* Cardiogenic sock including initial lactate level \\>18 mg/dL, necessary of vasopressor to keep mean artery pressure \\>65mmHg after adequate fluid supply, and signs of reduced cardiac output including disturbance consciousness, cold limbs, decreased urine output, acute pulmonary congestion and so on.\n\nExclusion Criteria:\n\n* Patient or family refuse\n* Metastatic cancer\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02633358', 'briefTitle': 'Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock Via Interleukin-6 Trans-signaling', 'orgStudyIdInfo': {'id': 'CMUH104-REC3-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic hypothermia group', 'description': 'Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling', 'interventionNames': ['Device: Therapeutic hypothermia group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No therapeutic hypothermia for controlled data.'}], 'interventions': [{'name': 'Therapeutic hypothermia group', 'type': 'DEVICE', 'description': 'Therapeutic hypothermia', 'armGroupLabels': ['Therapeutic hypothermia group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Da-Long Chen, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chnia Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}