Clinical trial NCT04975867: Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning
Official title: Targeted Temperature Management Combined With Hyperbaric Oxygen Therapy in Acute Severe Carbon Monoxide Poisoning: Multicenter Randomized Controlled Clinical Trial (TTM-COHB Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carbon Monoxide Poisoning
Neurologic Sequelae
Hypothermia
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2021-07-26
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Main neurocognitive outcome
timeFrame: At 6 months after CO poisoning
Secondary outcomes:
measure: Neurocognitive outcome
timeFrame: At 1 month after CO poisoning
measure: Cerebral Performance Category
timeFrame: At 1 month and 6 months after CO poisoning
measure: modified Rankin scale
timeFrame: At 1 month and 6 months after CO poisoning
measure: Glasgow outcome scale
timeFrame: At 1 month and 6 months after CO poisoning
measure: mini-mental status exam
timeFrame: At 1 month and 6 months after CO poisoning
measure: Korean version of the Modified Barthel Index
timeFrame: At 1 month and 6 months after CO poisoning
measure: Mortality in intensive care unit
timeFrame: Through study completion, an average of 6 months
measure: Mortality in intensive care unit
timeFrame: Through study completion, an average of 6 months
measure: In-hospital mortality
timeFrame: Through study completion, an average of 6 months
measure: In-hospital mortality
timeFrame: Through study completion, an average of 6 months
measure: Mortality
timeFrame: At 1, 3, and 6 months after CO poisoning
measure: Mortality
timeFrame: At 1, 3, and 6 months after CO poisoning
measure: Length of stay in intensive care unit and hospital
timeFrame: Through study completion, an average of 6 months
measure: Pneumonia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Pneumonia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Shock
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Shock
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Bradycardia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Bradycardia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hypokalemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hypokalemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hyperkalemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hyperkalemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hyperglycemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hyperglycemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hypophosphatemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hypophosphatemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hypomagnesemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Hypomagnesemia
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Prolonged prothrombin Time International Normalized Ratio
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Prolonged prothrombin Time International Normalized Ratio
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Prolonged activated partial thromboplastin time
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: Prolonged activated partial thromboplastin time
timeFrame: During the intervention (therapeutic hypothermia or normothermia) period (72 hours)
measure: S100ß (serum)
timeFrame: Within 14 days after CO exposure
measure: Neuronal specific enolase (serum)
timeFrame: Within 14 days after CO exposure
measure: Brain magnetic resonance image (MRI)
timeFrame: Within 14 days after CO exposure
measure: Brain magnetic resonance image (MRI)
timeFrame: Within 14 days after CO exposure
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Yong Sung Cha, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.