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Effectiveness of Mild Induced Hypothermia in heatstroke patients admitted to ICU: A pilot multicenter Randomized Clinical Trial

Effectiveness of Mild Induced Hypothermia in heatstroke patients admitted to ICU: A pilot multicenter Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094649
Enrollment
Unknown
Registered
2024-12-25
Start date
2024-05-18
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heatstroke

Interventions

Hypothermia group:Induced low temperature, target temperature 35 ? a. Cooling stage: Adopt any one or a combination of the following measures to cool down Ice blanket, fan, cold water bag, cold plasti
Normothermia:conventional therapy a. The diagnosis and treatment strategy determined by the attending physician. b. Do not intervene in the patients body temperature if it does not exceed 37.5 ? c. I

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form and comply with the requirements of the protocol; 2. Age range of 18 to 75 years old (including 18 and 75 years old); 3. Satisfy any medical history information and any clinical presentation, and the patient's clinical presentation cannot be explained by other reasons: Medical history information: a. Exposure to high temperature and high humidity environments (relative humidity above 90%, temperature above 30 degrees Celsius); b. High intensity exercise (equivalent to brisk walking at around 7 kilometers per hour, jogging at least 8 kilometers per hour, and cycling at around 20 kilometers per hour) Clinical manifestations: a. Symptoms of central nervous system dysfunction (such as coma, convulsions, delirium, abnormal behavior, etc.) b. Core temperature exceeds 40 ?; c. Multiple organ (= 2) functional damage manifestations (liver, kidney, striated muscle, gastrointestinal tract, etc.); d. Severe coagulation dysfunction or DIC; 4. The exposure time to high temperature and high humidity environment or the start time of high-intensity exercise should not exceed 24 hours from the ICU admission time; 5. Tracheal intubation due to consciousness impairment (FOUR score less than 4 points); 6. Expected tracheal intubation time greater than 48 hours.

Exclusion criteria

Exclusion criteria: 1. Patients with combined central nervous system diseases, including cerebral hemorrhage, extensive cerebral infarction, subarachnoid hemorrhage, and cerebral infarction, inflammation, meningitis, epilepsy, etc; 2. It cannot be ruled out that multiple organ failure is caused by infection in patients; 3. Patients with hypoglycemic coma, hyperosmolar coma, hepatic encephalopathy, and uremic encephalopathy; 4. Pregnant or lactating women; 5. Patients with chronic COPD requiring long-term oxygen therapy; 6. Life expectancy is less than 48 hours; 7. Has participated in other clinical studies; 8. Other situations that researchers believe are not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
28 days after randomization, the proportion of patients with poor functional results was measured using the mRS scale (mRS 0-3 and 4-6);

Secondary

MeasureTime frame
28 day all-cause mortality rate;Incidence of organ failure within 28 days: Renal failure, respiratory failure, circulatory failure, neurological dysfunction, liver failure, coagulation dysfunction;Quality of life: HRQoL;

Countries

China

Contacts

Public ContactQin Wu

West China Hospital of Sichuan University, Wuhou District, Chengdu City, Sichuan Province, China

qinwu0221@gmail.com+86 189 8060 5920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026