Targeted Temperature Management Via Bladder Monitoring in ICH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorYanyan Gong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bladder Temperature Monitoring
DeviceThis 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).
Standard Temperature Monitoring Group
DeviceAxillary 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.
Treatment groups
318 Participants
are divided into 2 treatment groupsGroup A: Bladder Temperature Monitoring GroupExperimental treatment 1 intervention
Group B: Standard Temperature Monitoring GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with mRS 0-2 at 180 days post-onset
The proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0 to 2, at 180 days (±14 days) post-onset. The mRS is a standardized measure of neurological disability ranging from 0 (no symptoms) to 6 (death). A score of 0-2 represents a favorable functional outcome.
Time frame
180 days post-onset（±14 days）Secondary outcomes
1
Daily mean fever burden
Calculated as the area under the curve (AUC) of temperature above the fever threshold (defined as ≥38.0°C)
Time frame
From enrollment until ICU discharge, meeting hospital discharge criteria, or up to 14 days (336 hours) (whichever occurs first)2
Total hospitalization costs
Time frame
From enrollment until hospital discharge3
Percentage of patients with mRS 0-2 at 90 days post-onset.
Time frame
90 days post-onset（±14 days）4
Neurological function assessed by GOS at 90 days
Time frame
90 days post-onset（±14 days）Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yanyan Gong
Lead sponsor
Second Affiliated Hospital of Nanchang University
Sponsor institution
First Affiliated Hospital of Gannan Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Zhejiang University
Collaborator
The First People's Hospital of Changde City
Collaborator
The First People's Hospital of Xiushui
Collaborator
Yichang Central People's Hospital
Collaborator
Source ClinicalTrials.gov