Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

Subarachnoid Hemorrhage Clinical Trial

— MERCURY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101537
• Other study ID #: HX-B-2023067
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: Liang Wu, MD
• Phone: 15001333582
• Email: wuliang[@]bjtth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Pressure
• Subarachnoid Hemorrhage
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Patterns of brain temperature-brain pressure in acute brain injury	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.	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Primary	Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with 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" ).	30 days after acute brain injury
Secondary	Rhythmic patterns of brain temperature in acute brain injury	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.	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Secondary	Predictive value of brain temperature rhythmic patterns on prognosis and neurological function in patients with 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" )	30 days after acute brain injury
Secondary	Differences in brain temperature-brain pressure correlation patterns by injury type	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.	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Secondary	Number of participants with brain temperature-pressure-related adverse events	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.	At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring