RecruitingNot ApplicableNCT07302009

Targeted Temperature Management Via Bladder Monitoring in ICH

Safety and Efficacy of Bladder Temperature Monitoring-Guided Targeted Temperature Management in Patients With Severe : A Multicenter Randomized Controlled Trial

Sponsor

Yanyan Gong

Enrollment

318 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Intracerebral Hemorrhage Targeted Temperature Management

Summary

The goal of this clinical trial is to learn whether a bladder temperature monitoring-guided targeted temperature management (TTM) strategy improves functional recovery in patients with severe intracerebral hemorrhage, compared to conventional temperature monitoring. It will also assess the safety of this monitoring approach. The main questions it aims to answer are: * Does continuous bladder temperature monitoring-guided TTM improve the likelihood of a favorable functional outcome (modified Rankin Scale score 0-2) at 180 days after onset? * What medical problems (such as infections, shivering, deep vein thrombosis, or sepsis) do participants experience while under the TTM strategy? Researchers will compare the intervention group (using continuous bladder temperature monitoring) with the control group (using conventional intermittent temperature monitoring with a mercury thermometer at the armpit) to see if the bladder temperature-guided TTM strategy leads to better outcomes. Participants will: * Be randomly assigned to one of the two temperature monitoring strategies * Receive standard medical and surgical care for severe intracerebral hemorrhage

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

Neurocritical care patients: Study subjects are patients with first-time spontaneous intracerebral hemorrhage.
Age ≥ 18 years and ≤ 85 years.
Glasgow Coma Scale (GCS) score ≤ 8 at ICU admission.
For supratentorial ICH: Hematoma volume < 60 mL. For subarachnoid hemorrhage (SAH): Modified Fisher grade ≥ 2, and the aneurysm has been treated with endovascular intervention.
Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.
Signed informed consent provided by a legally authorized representative.

Exclusion Criteria8

Fever (≥38.0°C) that lasted over 1 hour or occurred more than once prior to enrollment.
Pre-existing neurological, psychiatric, or other comorbidities that may compromise the assessment of neurological or functional outcomes.
Underlying conditions with a life expectancy of less than 6 months, estimated prior to onset.
Severe injury indicative of poor prognosis: brain death, receiving palliative care only, or irreversible brain injury.
Pregnancy.
Unilateral or bilateral pupillary dilation.
Currently participating in other investigational/interventional clinical trials (involving medical devices or drugs).
Subjects deemed ineligible for enrollment by the investigator.

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Interventions

DEVICEBladder Temperature Monitoring

This intervention utilizes a single-use, sterile, thermometric silicone urinary catheter that, upon insertion, provides continuous, real-time measurement of core body temperature, which is used to dynamically guide all phases of Targeted Temperature Management (TTM).

DEVICEStandard Temperature Monitoring Group

Axillary temperature is measured intermittently using a mercury-in-glass thermometer. The thermometer is placed in the axilla for a standardized period (e.g., 5-10 minutes) to obtain a reading. Temperature data is recorded every 4 hours and is used to guide adjustments in Targeted Temperature Management (TTM) therapy.