MERCURY: Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06101537

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Pressure Brain Injuries, Traumatic Subarachnoid Hemorrhage Cerebral Hemorrhage	Device: Brain temperature-pressure monitoring

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury：a Multicenter Prospective Cohort Study, MERCURY

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Brain temperature-pressure monitoring group 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.	Device: Brain temperature-pressure monitoring An intracranial pressure monitoring device that continuously records brain temperature-pressure data was used during treatment.

Arm

Intervention/Treatment

Brain temperature-pressure monitoring group

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.

Device: Brain temperature-pressure monitoring

An intracranial pressure monitoring device that continuously records brain temperature-pressure data was used during treatment.

Outcome Measures

Primary Outcome Measures

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.
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" ).

Secondary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

GCS ≥13 points;
Patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors;
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;
Maternity;
Undergoing experimental drug or instrumental trials.