Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-01 @ 12:23 PM
Study NCT ID:
NCT04975867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002249', 'term': 'Carbon Monoxide Poisoning'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D005739', 'term': 'Gas Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007036', 'term': 'Hypothermia, Induced'}], 'ancestors': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors of neurocognitive outcomes at 1 and 6 months after CO exposure will be blinded to the allocated treatment group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main neurocognitive outcome', 'timeFrame': 'At 6 months after CO poisoning', 'description': 'Global Deterioration Scale \\[range 1 - 7 (worst score)\\]'}], 'secondaryOutcomes': [{'measure': 'Neurocognitive outcome', 'timeFrame': 'At 1 month after CO poisoning', 'description': 'Global Deterioration Scale \\[range 1 - 7 (worst score)\\]'}, {'measure': 'Cerebral Performance Category', 'timeFrame': 'At 1 month and 6 months after CO poisoning', 'description': 'Cerebral Performance Category \\[range 1 - 5 (worst score)\\]'}, {'measure': 'modified Rankin scale', 'timeFrame': 'At 1 month and 6 months after CO poisoning', 'description': 'modified Rankin scale \\[range 0 - 6 (worst score)\\]'}, {'measure': 'Glasgow outcome scale', 'timeFrame': 'At 1 month and 6 months after CO poisoning', 'description': 'Glasgow outcome scale \\[range 1 (worst score) - 5\\]'}, {'measure': 'mini-mental status exam', 'timeFrame': 'At 1 month and 6 months after CO poisoning', 'description': 'mini-mental status exam'}, {'measure': 'Korean version of the Modified Barthel Index', 'timeFrame': 'At 1 month and 6 months after CO poisoning', 'description': 'Korean version of the Modified Barthel Index'}, {'measure': 'Mortality in intensive care unit', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Number of participants with mortality in intensive care unit'}, {'measure': 'Mortality in intensive care unit', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Rate of participants with mortality in intensive care unit'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Number of participants with in-hospital mortality'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Rate of participants with in-hospital mortality'}, {'measure': 'Mortality', 'timeFrame': 'At 1, 3, and 6 months after CO poisoning', 'description': 'Number of participants with all cause mortality'}, {'measure': 'Mortality', 'timeFrame': 'At 1, 3, and 6 months after CO poisoning', 'description': 'Rate of participants with all cause mortality'}, {'measure': 'Length of stay in intensive care unit and hospital', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Length of stay in intensive care unit and hospital'}, {'measure': 'Pneumonia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with the diagnosis of pneumonia. Diagnosis is established when the following two criteria are met: 1) the appearance of a new infiltrate or consolidation on chest x-ray; and 2) leukocytosis, or leukopenia, or the significant presence of meaningful bacteria in a sputum culture with the absence of other infections.'}, {'measure': 'Pneumonia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with the diagnosis of pneumonia. Diagnosis is established when the following two criteria are met: 1) the appearance of a new infiltrate or consolidation on chest x-ray; and 2) leukocytosis, or leukopenia, or the significant presence of meaningful bacteria in a sputum culture with the absence of other infections.'}, {'measure': 'Shock', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with shock. Diagnosis is diagnosed when a vasopressor is needed to resuscitate the patient and lactate levels exceeded 2.0 mmol/L.'}, {'measure': 'Shock', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with shock. Diagnosis is diagnosed when a vasopressor is needed to resuscitate the patient and lactate levels exceeded 2.0 mmol/L.'}, {'measure': 'Bradycardia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with dropped heart rate indicated drug or interventions'}, {'measure': 'Bradycardia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with dropped heart rate indicated drug or interventions'}, {'measure': 'Hypokalemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with serum K concentration \\<3.0 - 2.5 mmol/L'}, {'measure': 'Hypokalemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with serum K concentration \\<3.0 - 2.5 mmol/L'}, {'measure': 'Hyperkalemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with serum K concentration \\>6.0 - 7.0 mmol/L'}, {'measure': 'Hyperkalemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with serum K concentration \\>6.0 - 7.0 mmol/L'}, {'measure': 'Hyperglycemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose'}, {'measure': 'Hyperglycemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose'}, {'measure': 'Hypophosphatemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with a disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood and indicated replacement therapy'}, {'measure': 'Hypophosphatemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with a disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood and indicated replacement therapy'}, {'measure': 'Hypomagnesemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with serum magnesium \\<0.9 - 0.7 mg/dL'}, {'measure': 'Hypomagnesemia', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with serum magnesium \\<0.9 - 0.7 mg/dL'}, {'measure': 'Prolonged prothrombin Time International Normalized Ratio', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with \\>2.5 x upper limit of the normal range and bleeding'}, {'measure': 'Prolonged prothrombin Time International Normalized Ratio', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with \\>2.5 x upper limit of the normal range and bleeding'}, {'measure': 'Prolonged activated partial thromboplastin time', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Number of participants with \\>2.5 x upper limit of the normal range and bleeding'}, {'measure': 'Prolonged activated partial thromboplastin time', 'timeFrame': 'During the intervention (therapeutic hypothermia or normothermia) period (72 hours)', 'description': 'Rate of participants with \\>2.5 x upper limit of the normal range and bleeding'}, {'measure': 'S100ß (serum)', 'timeFrame': 'Within 14 days after CO exposure', 'description': 'Concentration of S100ß (serum)'}, {'measure': 'Neuronal specific enolase (serum)', 'timeFrame': 'Within 14 days after CO exposure', 'description': 'Concentration of neuronal specific enolase (serum)'}, {'measure': 'Brain magnetic resonance image (MRI)', 'timeFrame': 'Within 14 days after CO exposure', 'description': 'Number of participants with brain injury in brain MRI'}, {'measure': 'Brain magnetic resonance image (MRI)', 'timeFrame': 'Within 14 days after CO exposure', 'description': 'Rate of participants with brain injury in brain MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbon Monoxide Poisoning', 'Neurologic Sequelae', 'Hypothermia']}, 'referencesModule': {'references': [{'pmid': '32697512', 'type': 'BACKGROUND', 'citation': 'Kim SJ, Thom SR, Kim H, Hwang SO, Lee Y, Park EJ, Lee SJ, Cha YS. Effects of Adjunctive Therapeutic Hypothermia Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning. Crit Care Med. 2020 Aug;48(8):e706-e714. doi: 10.1097/CCM.0000000000004419.'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial will investigate important neurocognitive clinical outcomes of patients with acute severe carbon monoxide poisoning (ASCOP) randomized to receive either therapeutic hypothermia or normothermia combined with hyperbaric oxygen therapy (HBO).', 'detailedDescription': 'CO-poisoned patients are identified by medical history and carboxyhemoglobin (CO-Hb) value \\>5% (\\>10% in smokers). Patients presenting with acute CO poisoning will receive one HBO. ASCOP is defined as mental status showing response to painful stimulus or unresponsiveness requiring intubation for airway protection and ventilation support at the emerency department, and persistence of depressed mental status despite the HBO. After HBO treatment, eligible patients who provide consent will be randomly allocated to receive hypothermia, or normothermia treatment administered in a open label fashion except for blinding of outcome assessor.\n\nOutcome measures will be administered at 1 month and 6 months after CO exposure. In addition, we will examine the differences in serum markers and mortality between the hypothermia and normothermia groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 19 years.\n* Patients who received HBO within 24 hours for acute CO poisoning.\n* Patients who meet the definition of ASCOP (Patients incapable verbal obey after HBO).\n* Signed informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Cardiac arrest before HBO\n* Previous neurocognitive disorders\n* Life-threatening underlying disease (ex: advanced cancer)\n* Evidence of co-ingestion of sedative or hypnotics confirmed by intravenous flumazenil administration or history taking at the emergency department\n* Absolute contraindication for TH (active severe bleeding and profound shock not controlled by vasoactive drugs)\n* No admission\n* The significant co-ingested drug levels, which are alter the consciousness, is confirmed from the drug analysis lab\n* Pregnancy\n* Burns\n* More than moderate burn or Inhalation burn\n* Burns complicated by other trauma\n* Electrical burn\n* Burns in high risk patients (Patients with chronic underlying diseases (i.e DM, ESRD, liver cirrhosis, etc) which may cause delays or aggravate the wound healing)'}, 'identificationModule': {'nctId': 'NCT04975867', 'briefTitle': 'Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Targeted Temperature Management Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning: Multicenter Randomized Controlled Clinical Trial (TTM-COHB Trial)', 'orgStudyIdInfo': {'id': 'TTM-COHB trial'}, 'secondaryIdInfos': [{'id': 'CR220011', 'type': 'OTHER', 'domain': 'Wonju Severance Christian Hospital'}, {'id': '2021-04-043', 'type': 'OTHER', 'domain': 'Inha University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypothermia group', 'description': 'Hypothermia group is then performed at a body temperature of 33±0.5 °C during 24 h using a surface cooling device as soon as possible after the HBO and research consent. After therapeutic hypothermia ended, rewarming is done slowly between 0.2℃ - 0.5℃/h for 12 hours. After rewarming, it will be held at 36.5 ℃ for 36 hours.', 'interventionNames': ['Other: Targeted therapeutic hypothermia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normothermia group', 'description': 'For normothermia group, it will be held at 36.5±0.5 ℃ for 72 hours using a surface cooling device after the HBO and research consent.', 'interventionNames': ['Other: Targeted therapeutic normothermia']}], 'interventions': [{'name': 'Targeted therapeutic hypothermia', 'type': 'OTHER', 'description': 'Targeted therapeutic hypothermia is then performed at a body temperature of 33±0.5 °C during 24 h using a surface cooling device as soon as possible after the HBO and research consent. After TH ended, rewarming is done slowly between 0.2℃ - 0.5℃/h for 12 hours. After rewarming, it will be held at 36.5 ℃ for 36 hours.', 'armGroupLabels': ['Hypothermia group']}, {'name': 'Targeted therapeutic normothermia', 'type': 'OTHER', 'description': 'Targeted therapeutic normothermia will be held at 36.5±0.5 ℃ for 72 hours using a surface cooling device after the HBO and research consent.', 'armGroupLabels': ['Normothermia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '22332', 'city': 'Incheon', 'state': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Yong Sung Cha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonju Severance Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yong Sung Cha', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}