- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101537
Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury (MERCURY)
February 5, 2026 updated by: Beijing Tiantan Hospital
Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury:a Multicenter Prospective Cohort Study, MERCURY
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
208
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
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An intracranial pressure monitoring device that continuously records brain temperature-pressure data was used during treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Patterns of brain temperature-brain pressure in acute brain injury
Time Frame: 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.
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At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
|
|
Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury
Time Frame: 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" ).
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30 days after acute brain injury
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rhythmic patterns of brain temperature in acute brain injury
Time Frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
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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.
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At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
|
|
Predictive value of brain temperature rhythmic patterns on prognosis and neurological function in patients with acute brain injury
Time Frame: 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" )
|
30 days after acute brain injury
|
|
Differences in brain temperature-brain pressure correlation patterns by injury type
Time Frame: 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.
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At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
|
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Number of participants with brain temperature-pressure-related adverse events
Time Frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guoyi Gao, MD, Beijing Tiantan Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Actual)
July 24, 2025
Study Completion (Actual)
July 24, 2025
Study Registration Dates
First Submitted
October 18, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Pathologic Processes
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Pathological Conditions, Signs and Symptoms
- Brain Injuries, Traumatic
- Brain Injuries
- Cerebral Hemorrhage
- Subarachnoid Hemorrhage
Other Study ID Numbers
- HX-B-2023067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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