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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116636
Enrollment
Unknown
Registered
2026-01-13
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Spontaneous Intracerebral Hemorrhage

Interventions

Intervention group:Real-time bladder temperature monitoring was performed using a single-use, sterile, thermometric silicone urinary catheter to guide targeted temperature management. Based on the rea
Control group:Axillary temperature was measured with a mercury thermometer to guide targeted temperature management. Based on the monitoring data, cooling or rewarming measures were adjusted. Body tem

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Neurocritical care patients: Study subjects are patients with first-time spontaneous intracerebral hemorrhage. 2. Age >= 18 years and = 2, and the aneurysm has been treated with endovascular intervention; 5. Pre-morbid modified Rankin Scale (mRS) score of 0 or 1; 6. Signed informed consent provided by a legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Fever (>=38.0°C) that lasted over 1 hour or occurred more than once prior to enrollment; 2. Pre-existing neurological, psychiatric, or other comorbidities that may compromise the assessment of neurological or functional outcomes; 3. Underlying conditions with a life expectancy of less than 6 months, estimated prior to onset; 4. Severe injury indicative of poor prognosis: brain death, receiving palliative care only, or irreversible brain injury; 5. Pregnancy; 6. Unilateral or bilateral pupillary dilation; 7. Currently participating in other investigational/interventional clinical trials (involving medical devices or drugs); 8. Subjects deemed ineligible for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
mRS score of 0~2;

Secondary

MeasureTime frame
Daily mean fever burden;mRS score of 0~2;GOS score assessed ;GOS score ;NIHSS score ;NIHSS score ; Length of stay in the Intensive Care Unit (ICU);Total duration of hospital stay;Total hospitalization costs;Infection rate (pneumonia, urinary tract infection);DVT Incidence;hivering Frequency;Sepsis Incidence;Malignant Edema Incidence;All-cause mortality;

Countries

China

Contacts

Public ContactYanyan Gong

The Second Affiliated Hospital of Nanchang University

Gongyy0619@163.com+86 791 8664 9374

Outcome results

None listed

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