Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning
- Conditions
- Carbon Monoxide PoisoningHypothermiaNeurologic Sequelae
- Interventions
- Other: Targeted therapeutic normothermiaOther: Targeted therapeutic hypothermia
- Registration Number
- NCT04975867
- Lead Sponsor
- Wonju Severance Christian Hospital
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- ≥ 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normothermia group Targeted therapeutic normothermia 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. Hypothermia group Targeted therapeutic hypothermia 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.
- Primary Outcome Measures
Name Time Method Main neurocognitive outcome At 6 months after CO poisoning Global Deterioration Scale \[range 1 - 7 (worst score)\]
- Secondary Outcome Measures
Name Time Method Cerebral Performance Category At 1 month and 6 months after CO poisoning Cerebral Performance Category \[range 1 - 5 (worst score)\]
modified Rankin scale At 1 month and 6 months after CO poisoning modified Rankin scale \[range 0 - 6 (worst score)\]
Glasgow outcome scale At 1 month and 6 months after CO poisoning Glasgow outcome scale \[range 1 (worst score) - 5\]
mini-mental status exam At 1 month and 6 months after CO poisoning mini-mental status exam
Korean version of the Modified Barthel Index At 1 month and 6 months after CO poisoning Korean version of the Modified Barthel Index
Mortality in intensive care unit Through study completion, an average of 6 months Rate of participants with mortality in intensive care unit
In-hospital mortality Through study completion, an average of 6 months Rate of participants with in-hospital mortality
Mortality At 1, 3, and 6 months after CO poisoning Rate of participants with all cause mortality
Shock 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.
Hypomagnesemia During the intervention (therapeutic hypothermia or normothermia) period (72 hours) Rate of participants with serum magnesium \<0.9 - 0.7 mg/dL
Prolonged prothrombin Time International Normalized Ratio 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
Neurocognitive outcome At 1 month after CO poisoning Global Deterioration Scale \[range 1 - 7 (worst score)\]
Prolonged activated partial thromboplastin time 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
Length of stay in intensive care unit and hospital Through study completion, an average of 6 months Length of stay in intensive care unit and hospital
Pneumonia 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.
Bradycardia During the intervention (therapeutic hypothermia or normothermia) period (72 hours) Rate of participants with dropped heart rate indicated drug or interventions
Hypokalemia During the intervention (therapeutic hypothermia or normothermia) period (72 hours) Rate of participants with serum K concentration \<3.0 - 2.5 mmol/L
S100ß (serum) Within 14 days after CO exposure Concentration of S100ß (serum)
Neuronal specific enolase (serum) Within 14 days after CO exposure Concentration of neuronal specific enolase (serum)
Hyperkalemia During the intervention (therapeutic hypothermia or normothermia) period (72 hours) Rate of participants with serum K concentration \>6.0 - 7.0 mmol/L
Hyperglycemia 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
Hypophosphatemia 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
Brain magnetic resonance image (MRI) Within 14 days after CO exposure Rate of participants with brain injury in brain MRI
Trial Locations
- Locations (2)
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon, Korea, Republic of