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

Qualifiers

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

Treatments tested in this trial

  • Bladder Temperature Monitoring
  • Standard Temperature Monitoring Group

Treatment groups

318 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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