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临床试验/NCT06101537
NCT06101537
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Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury:a Multicenter Prospective Cohort Study, MERCURY

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 208 人2024年2月15日

概览

阶段
不适用
干预措施
Brain temperature-pressure monitoring
疾病 / 适应症
Intracranial Pressure
发起方
Beijing Tiantan Hospital
入组人数
208
试验地点
1
主要终点
Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury
状态
已完成
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年2月15日
结束日期
2025年7月24日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

发起方
Beijing Tiantan Hospital
责任方
Sponsor

入排标准

入选标准

  • 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.

排除标准

  • 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;
  • Undergoing experimental drug or instrumental trials.

研究组 & 干预措施

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.

干预措施: Brain temperature-pressure monitoring

结局指标

主要结局

Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury

时间窗: 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

时间窗: 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.

次要结局

  • Rhythmic patterns of brain temperature in acute brain injury(At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring)
  • Number of participants with brain temperature-pressure-related adverse events(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(30 days after acute brain injury)
  • 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)

研究点 (1)

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