Endovascular Catheter Rewarming for Accidental Severe Hypothermia

JRCT ID: jRCT1012240051

Registered date:20/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: accidental hypothermia
• Date of first enrollment: 20/11/2024
• Target sample size: 88
• Study type: Interventional

Intervention(s)

Intervention(s):
Intravascular catheter+Conventional rewarming group:
Rewarming therapy to 36 degrees using an intravascular catheter and the conventional rewarming method.

Conventional rewarming group:
Rewarming therapy to 36 degrees (or combination)using a warm air blanket, electric blanket, or heating pad. However, it does not include active internal core rewarming such as ECMO, Hemodialysis, thoracic, or peritoneal lavage.

Outcome(s)

• Primary Outcome: Comparison of the percentage of patients achieving a rewarming rate >=1.5 degrees/h in groups with and without intravascular catheter rewarming therapy.

Secondary Outcome

Comparison of groups with and without intravascular catheter rewarming therapy as follows:
Rewarming rate of core body temperature to 36 degrees, percentage of core body temperature rewarming to 36 degrees achieved, rewarming rate from the start of intravascular catheter rewarming (rewarming rate from the start of conventional rewarming therapy), ventilator days, renal replacement therapy (RRT) days, catecholamine administration days, Length of stay at ICU, adverse event rates, Outcome and CPC at discharge.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age 65 years or older at the time of emergency transport
2. Core body temperature measured in the emergency room is less than 30 degrees Celsius and patients diagnosed with accidental hypothermia having preserved circulation
3. Informed consent obtained from the research participants or their representatives

Exclude criteria

1. Patients with cardiac arrest at pre-hospital or on arrival at the hospital
2. Hospital transfer patient
3. Patients who cannot access a central venous catheter from the femoral vein
4. Patients who are unable to perform core body temperature monitoring due to trauma or other damage
5. Patients with hypersensitivity reactions to heparin
6. Patients with blood disorders worsened by hypothermia
7. Other patients who are judged to be inadequate as research participants by the investigator

Related Information

• Primary Sponsor: Hayakawa Mineji
• Source(s) of Monetary Support: Grant-in-aid for multicenter clinical research from Japanese Association for Acute Medicine,Hokkaido University Hospital