Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

Recruiting

• Conditions: Cerebral Hemorrhage; Subarachnoid Hemorrhage; Intracranial Pressure; Brain Injuries, Traumatic
• Interventions: Device: Brain temperature-pressure monitoring

• Registration Number: NCT06101537
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

The goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury.

Detailed Description

Temperature abnormalities have long been recognized as signs of disease. Brain temperature, as part of body temperature, reflects body temperature and brain metabolism during physiologic states. There is growing evidence that brain cell function is unequivocally temperature dependent and that brain temperature after brain injury cannot be reliably predicted by core body temperature. Brain temperature is therefore increasingly becoming an important alternative to brain pressure, enabling patients with a variety of brain injuries to benefit from continuous brain temperature monitoring. Meanwhile, the correlation between intracranial pressure, which is currently the most widely used indicator in clinical practice, and brain temperature in patients with acute brain injury remains unelucidated. Whether the correlation between brain temperature and intracranial pressure has certain patterns and rhythms that can indirectly reflect the brain function of patients under the condition of injury and have a predictive value for clinical outcomes is the main research objective of this study. It is hoped that the present study will explore the correlation between brain temperature and brain pressure and the pattern of the correlation, as well as its impact on clinical prognosis. It provides a more precise target for intervention to further improve the prognosis of patients with acute brain injury.

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-26
• Study Start: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Adults, male or female, 18 to 65 years of age;
2. Acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, or craniocerebral trauma;
3. Glasgow Coma Scale (GCS) score of 3-12;
4. Have undergone intracranial pressure monitoring probe placement, which allows continuous recording of brain temperature and pressure data;
5. Signed informed consent.

Exclusion Criteria

1. GCS ≥13 points;
2. Patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors;
3. At the time of onset, there was a combination of systemic malignant tumor, acute stage of major systemic organ disease, or stage of functional decompensation;
4. Maternity;
5. Undergoing experimental drug or instrumental trials.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain temperature-pressure monitoring group	Brain temperature-pressure monitoring	From a neurointensive care unit with intracranial pressure monitoring during treatment, which allows continuous recording of brain temperature-pressure data, in patients with moderate and severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma.

Primary Outcome Measures

Name	Time	Method
Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury	30 days after acute brain injury	Predictive value of the brain temperature-brain pressure correlation patterns on the prognosis and neurological function of patients after acute brain injury as clarified by patients' Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" ).
Correlation Patterns of brain temperature-brain pressure in acute brain injury	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring	By using a brain temperature-pressure monitoring device, the correlation was analyzed by continuously recording brain temperature-pressure data and plotting time-brain temperature and time-brain pressure curves in patients with moderate and severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma.

Secondary Outcome Measures

Name	Time	Method
Rhythmic patterns of brain temperature in acute brain injury	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring	To explore the rhythmic pattern of brain temperature in acute brain injury by using a brain temperature-pressure monitoring device, obtaining continuous brain temperature data, and plotting the brain temperature-time curve.
Number of participants with brain temperature-pressure-related adverse events	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring	After obtaining the predictive value of the brain temperature-pressure correlation patterns for prognosis and neurological function in patients with acute brain injury, the number of participants with associated adverse events was assessed by CTCAE v4.0.
Predictive value of brain temperature rhythmic patterns on prognosis and neurological function in patients with acute brain injury	30 days after acute brain injury	Predictive value of the brain temperature rhythmic patterns on the prognosis and neurological function of patients after acute brain injury as clarified by patients' Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" )
Differences in brain temperature-brain pressure correlation patterns by injury type	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring	By using a brain temperature-brain pressure monitoring device, brain temperature-brain pressure data were continuously recorded in patients with moderate and severe acute brain injuries due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma. And time-brain temperature and time-brain pressure curves were plotted to analyze the differences between different injury types.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China