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| ID | Type | Description | Link |
|---|---|---|---|
| CR220011 | Other Identifier | Wonju Severance Christian Hospital | |
| 2021-04-043 | Other Identifier | Inha University Hospital |
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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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).
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.
Outcome 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermia group | Experimental | 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. |
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| Normothermia group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted therapeutic hypothermia | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Main neurocognitive outcome | Global Deterioration Scale [range 1 - 7 (worst score)] | At 6 months after CO poisoning |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive outcome | Global Deterioration Scale [range 1 - 7 (worst score)] | At 1 month after CO poisoning |
| Cerebral Performance Category | Cerebral Performance Category [range 1 - 5 (worst score)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Sung Cha, MD | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea | ||
| Inha University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32697512 | Background | 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. |
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| ID | Term |
|---|---|
| D002249 | Carbon Monoxide Poisoning |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D005739 | Gas Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D001832 | Body Temperature Changes |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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Assessors of neurocognitive outcomes at 1 and 6 months after CO exposure will be blinded to the allocated treatment group.
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| Targeted therapeutic normothermia | Other | 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. |
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| At 1 month and 6 months after CO poisoning |
| modified Rankin scale | modified Rankin scale [range 0 - 6 (worst score)] | At 1 month and 6 months after CO poisoning |
| Glasgow outcome scale | Glasgow outcome scale [range 1 (worst score) - 5] | At 1 month and 6 months after CO poisoning |
| mini-mental status exam | mini-mental status exam | At 1 month and 6 months after CO poisoning |
| Korean version of the Modified Barthel Index | Korean version of the Modified Barthel Index | At 1 month and 6 months after CO poisoning |
| Mortality in intensive care unit | Number of participants with mortality in intensive care unit | Through study completion, an average of 6 months |
| Mortality in intensive care unit | Rate of participants with mortality in intensive care unit | Through study completion, an average of 6 months |
| In-hospital mortality | Number of participants with in-hospital mortality | Through study completion, an average of 6 months |
| In-hospital mortality | Rate of participants with in-hospital mortality | Through study completion, an average of 6 months |
| Mortality | Number of participants with all cause mortality | At 1, 3, and 6 months after CO poisoning |
| Mortality | Rate of participants with all cause mortality | At 1, 3, and 6 months after CO poisoning |
| Length of stay in intensive care unit and hospital | Length of stay in intensive care unit and hospital | Through study completion, an average of 6 months |
| Pneumonia | 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. | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Pneumonia | 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. | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Shock | 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. | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Shock | 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. | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Bradycardia | Number of participants with dropped heart rate indicated drug or interventions | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Bradycardia | Rate of participants with dropped heart rate indicated drug or interventions | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hypokalemia | Number of participants with serum K concentration <3.0 - 2.5 mmol/L | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hypokalemia | Rate of participants with serum K concentration <3.0 - 2.5 mmol/L | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hyperkalemia | Number of participants with serum K concentration >6.0 - 7.0 mmol/L | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hyperkalemia | Rate of participants with serum K concentration >6.0 - 7.0 mmol/L | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hyperglycemia | Number of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hyperglycemia | Rate of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hypophosphatemia | 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 | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hypophosphatemia | 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 | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hypomagnesemia | Number of participants with serum magnesium <0.9 - 0.7 mg/dL | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Hypomagnesemia | Rate of participants with serum magnesium <0.9 - 0.7 mg/dL | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Prolonged prothrombin Time International Normalized Ratio | Number of participants with >2.5 x upper limit of the normal range and bleeding | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Prolonged prothrombin Time International Normalized Ratio | Rate of participants with >2.5 x upper limit of the normal range and bleeding | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Prolonged activated partial thromboplastin time | Number of participants with >2.5 x upper limit of the normal range and bleeding | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| Prolonged activated partial thromboplastin time | Rate of participants with >2.5 x upper limit of the normal range and bleeding | During the intervention (therapeutic hypothermia or normothermia) period (72 hours) |
| S100ß (serum) | Concentration of S100ß (serum) | Within 14 days after CO exposure |
| Neuronal specific enolase (serum) | Concentration of neuronal specific enolase (serum) | Within 14 days after CO exposure |
| Brain magnetic resonance image (MRI) | Number of participants with brain injury in brain MRI | Within 14 days after CO exposure |
| Brain magnetic resonance image (MRI) | Rate of participants with brain injury in brain MRI | Within 14 days after CO exposure |
| Incheon |
| Incheon |
| 22332 |
| South Korea |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |