Clinical trial NCT06101537: Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury
Official title: Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury：a Multicenter Prospective Cohort Study, MERCURY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Pressure
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Keywords: brain temperature monitoring
intracranial pressure monitoring
severe brain injury
subarachnoid hemorrhage
cerebral hemorrhage
traumatic brain injury
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma from 20 centers with intracranial pressure monitoring during treatment, which allows continuous recording of brain temperature-brain pressure data.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation Patterns of brain temperature-brain pressure in acute brain injury
timeFrame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
measure: Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury
timeFrame: 30 days after acute brain injury
Secondary outcomes:
measure: Rhythmic patterns of brain temperature in acute brain injury
timeFrame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
measure: Predictive value of brain temperature rhythmic patterns on prognosis and neurological function in patients with acute brain injury
timeFrame: 30 days after acute brain injury
measure: Differences in brain temperature-brain pressure correlation patterns by injury type
timeFrame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
measure: Number of participants with brain temperature-pressure-related adverse events
timeFrame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Guoyi Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weng WJ, Yang C, Huang XJ, Zhang YM, Liu JF, Yao JM, Zhang ZH, Wu XS, Mei T, Zhang CD, Jia J, Shi XF, Mao Q, Feng JF, Gao GY, Jiang JY. Effects of Brain Temperature on the Outcome of Patients with Traumatic Brain Injury: A Prospective Observational Study. J Neurotrauma. 2019 Apr 1;36(7):1168-1174. doi: 10.1089/neu.2018.5881. Epub 2018 Oct 10.