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Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

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ClinicalTrials.gov Identifier: NCT04975867
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Yong Sung Cha, Wonju Severance Christian Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Carbon Monoxide Poisoning Neurologic Sequelae Hypothermia Other: Targeted therapeutic hypothermia Other: Targeted therapeutic normothermia Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors of neurocognitive outcomes at 1 and 6 months after CO exposure will be blinded to the allocated treatment group.
Primary Purpose: Treatment
Official Title: Targeted Temperature Management Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning: Multicenter Randomized Controlled Clinical Trial (TTM-COHB Trial)
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hypothermia group
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.
 Other: Targeted therapeutic hypothermia
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.
Active Comparator: Normothermia group
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.
 Other: Targeted therapeutic normothermia
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.


Outcome Measures
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Primary Outcome Measures :
  1. Main neurocognitive outcome [ Time Frame: At 6 months after CO poisoning ]
    Global Deterioration Scale [range 1 - 7 (worst score)]


Secondary Outcome Measures :
  1. Neurocognitive outcome [ Time Frame: At 1 month after CO poisoning ]
    Global Deterioration Scale [range 1 - 7 (worst score)]

  2. Cerebral Performance Category [ Time Frame: At 1 month and 6 months after CO poisoning ]
    Cerebral Performance Category [range 1 - 5 (worst score)]

  3. modified Rankin scale [ Time Frame: At 1 month and 6 months after CO poisoning ]
    modified Rankin scale [range 0 - 6 (worst score)]

  4. Glasgow outcome scale [ Time Frame: At 1 month and 6 months after CO poisoning ]
    Glasgow outcome scale [range 1 (worst score) - 5]

  5. mini-mental status exam [ Time Frame: At 1 month and 6 months after CO poisoning ]
    mini-mental status exam

  6. Korean version of the Modified Barthel Index [ Time Frame: At 1 month and 6 months after CO poisoning ]
    Korean version of the Modified Barthel Index

  7. Mortality in intensive care unit [ Time Frame: Through study completion, an average of 6 months ]
    Number of participants with mortality in intensive care unit

  8. Mortality in intensive care unit [ Time Frame: Through study completion, an average of 6 months ]
    Rate of participants with mortality in intensive care unit

  9. In-hospital mortality [ Time Frame: Through study completion, an average of 6 months ]
    Number of participants with in-hospital mortality

  10. In-hospital mortality [ Time Frame: Through study completion, an average of 6 months ]
    Rate of participants with in-hospital mortality

  11. Mortality [ Time Frame: At 1, 3, and 6 months after CO poisoning ]
    Number of participants with all cause mortality

  12. Mortality [ Time Frame: At 1, 3, and 6 months after CO poisoning ]
    Rate of participants with all cause mortality

  13. Length of stay in intensive care unit and hospital [ Time Frame: Through study completion, an average of 6 months ]
    Length of stay in intensive care unit and hospital

  14. Pneumonia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    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.

  15. Pneumonia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    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.

  16. Shock [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    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.

  17. Shock [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    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.

  18. Bradycardia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with dropped heart rate indicated drug or interventions

  19. Bradycardia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with dropped heart rate indicated drug or interventions

  20. Hypokalemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with serum K concentration <3.0 - 2.5 mmol/L

  21. Hypokalemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with serum K concentration <3.0 - 2.5 mmol/L

  22. Hyperkalemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with serum K concentration >6.0 - 7.0 mmol/L

  23. Hyperkalemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with serum K concentration >6.0 - 7.0 mmol/L

  24. Hyperglycemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose

  25. Hyperglycemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with change (Insulin therapy initiated) in daily management from baseline for serum glucose

  26. Hypophosphatemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    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

  27. Hypophosphatemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    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

  28. Hypomagnesemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with serum magnesium <0.9 - 0.7 mg/dL

  29. Hypomagnesemia [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with serum magnesium <0.9 - 0.7 mg/dL

  30. Prolonged prothrombin Time International Normalized Ratio [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with >2.5 x upper limit of the normal range and bleeding

  31. Prolonged prothrombin Time International Normalized Ratio [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with >2.5 x upper limit of the normal range and bleeding

  32. Prolonged activated partial thromboplastin time [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Number of participants with >2.5 x upper limit of the normal range and bleeding

  33. Prolonged activated partial thromboplastin time [ Time Frame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours) ]
    Rate of participants with >2.5 x upper limit of the normal range and bleeding

  34. S100ß (serum) [ Time Frame: Within 14 days after CO exposure ]
    Concentration of S100ß (serum)

  35. Neuronal specific enolase (serum) [ Time Frame: Within 14 days after CO exposure ]
    Concentration of neuronal specific enolase (serum)

  36. Brain magnetic resonance image (MRI) [ Time Frame: Within 14 days after CO exposure ]
    Number of participants with brain injury in brain MRI

  37. Brain magnetic resonance image (MRI) [ Time Frame: Within 14 days after CO exposure ]
    Rate of participants with brain injury in brain MRI


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 19 years.
  • Patients who received HBO within 24 hours for acute CO poisoning.
  • Patients who meet the definition of ASCOP (Patients incapable verbal obey after HBO).
  • Signed informed consent prior to study entry.

Exclusion Criteria:

  • Cardiac arrest before HBO
  • Previous neurocognitive disorders
  • Life-threatening underlying disease (ex: advanced cancer)
  • Evidence of co-ingestion of sedative or hypnotics confirmed by intravenous flumazenil administration or history taking at the emergency department
  • Absolute contraindication for TH (active severe bleeding and profound shock not controlled by vasoactive drugs)
  • No admission
  • The significant co-ingested drug levels, which are alter the consciousness, is confirmed from the drug analysis lab
  • Pregnancy
  • Burns
  • More than moderate burn or Inhalation burn
  • Burns complicated by other trauma
  • Electrical burn
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975867


Contacts
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Contact: Yong Sung Cha, MD +82-33-741-1615 emyscha@yonsei.ac.kr
Contact: Yoonsuk Lee, MD +82-33-741-1133 yslee524@gmail.com

Locations
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Korea, Republic of
Wonju Severance Christian Hospital Recruiting
Wonju, Gangwon, Korea, Republic of, 26426
Contact: Yong Sung Cha, MD    +82-33-741-1615    emyscha@yonsei.ac.kr   
Contact: Yoonsuk Lee, MD    +82-33-741-1133    yslee524@gmail.com   
Principal Investigator: Yong Sung Cha, MD         
Sub-Investigator: Yoonsuk Lee, MD         
Sub-Investigator: Hyun Kim, MD         
Sub-Investigator: Sang-yeol Yong, MD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Contact: Jin Hui Paik, MD    +82-32-890-2310    riven2ne@inha.ac.kr   
Contact: Soo Kang, MD    +82-32-890-2310    dr_peace@naver.com   
Principal Investigator: Jin Hui Paik, MD         
Sub-Investigator: Soo Kang, MD         
Sub-Investigator: Tae Kyu Ahn, MD         
Sub-Investigator: Young Ho Seo, MD         
Sub-Investigator: Kyung-Lim Joa, MD         
Sponsors and Collaborators
Wonju Severance Christian Hospital
National Research Foundation of Korea
Investigators
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Principal Investigator: Yong Sung Cha, MD Wonju Severance Christian Hospital
More Information
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Publications:

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Responsible Party: Yong Sung Cha, Assistant Professor, Wonju Severance Christian Hospital
ClinicalTrials.gov Identifier: NCT04975867    
Other Study ID Numbers: TTM-COHB trial
CR220011 ( Other Identifier: Wonju Severance Christian Hospital )
2021-04-043 ( Other Identifier: Inha University Hospital )
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypothermia
Poisoning
Carbon Monoxide Poisoning
 Body Temperature Changes
Chemically-Induced Disorders
Gas Poisoning