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临床试验/NCT05515640
NCT05515640进行中(未招募)不适用

Dysautonomia and Systemic Interactions in Traumatic Brain Injury

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
24
试验地点
1
主要终点
Stress biomarkers

研究概览

简要总结

Following brain injury, complex interactions between the nervous system and other organs are frequently encountered. Systemic effects may be induced by dysregulation of the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. This observational study will investigate the link between clinical, physiological and biochemical expressions of dysautonomic reactions and physiological stress, and their relations to sympathetic activation in traumatic brain injury patients treated in the neurointensive care unit.

详细描述

Following traumatic brain injury (TBI) complex interactions between the nervous system and other organs are frequently encountered. Systemic reactions may be induced by dys-regulation of the hypothalamic-pituitary adrenal (HPA) axis and the autonomic nervous system. Neuro-endocrine disturbances are common and up to 50 % of brain injured Neuro-intensive care (NICU) patients may exhibit a period of relative adreno-cortico insufficiency in the early phase of TBI, which in part may be centrally mediated. Catecholamine surge is thought responsible for cardio pulmonary reactions such as myocardial stunning, and may be an instrumental part of neurogenic pulmonary edema. An imbalance between the parasympathetic and sympathetic nervous system has been identified, and may even effect outcome, but is poorly understood. This is seen both in early and chronic stages of brain injury. Heart rate variability has been implicated as an indicator of dys-autonomic parasympathetic dysfunction, and has in small studies been related to TBI outcome. Recently a clinical definition of Paroxysmal Sympathetic Hyper-activation (PSH) has been suggested and identities as related to patient outcome.

Thus, in TBI the picture of a triad of dysautonomic and hypothalamic-pituitary dysregulation and injury driven inflammation, with a potential of bi-directional cross-talk between central and peripheral immuno- modulators, is emerging. This study will aim to explore and integrate indicators of these three components as to define phenotypes. It will investigate the utility of medically approved (CE) Skin Conductance Algesimeter (Med-Storm ®) in relation to other parameters of physiological stress including, heart rate variability (HRV), intra-cranial pressure reactivity index (PrX), and products of the HPA axis such as, ACTH, adrenaline and nor-adrenaline including break down products, markers of brain trauma driven neuro and systemic inflammation.

The investigators hypothesize that a limited number of composite patterns will emerge and may describe patient phenotypes with differing trajectories.

CRF:

Electronic case report form (eCRF) with pseudo anonymized data via a globally unique personal identifier (GUPI) to secure eCRF platform.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or over.
  • Patients suffering from TBI, in need of neurocritical care and intracranial pressure measurement

排除标准

  • Trauma more than 24 hours prior to inclusion. Goal for inclusion is less than 12 hours.
  • TBI unlikely to survive five days (as judged by clinical team, such as bilateral fixed and dilated pupils).
  • Follow up not possible

结局指标

主要结局

Stress biomarkers

时间窗: up to one week in ICU

Cortsol and adrengeric breakdown metabolites

Skin Conductance Algesimeter

时间窗: up to one week

the Skin Conductance Algometer (MedStorm (R)) as conductance in microvolts and algesimeter index as peaks/second.

次要结局

  • Exploratory hypothesis-generating analysis of interactions/crosstalk between dysautonomia, the hypothalamic-pituitary-adrenal axis and neuroinflammation.(Collected during ICU stay up to one week.)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Nelson, MD , PhD

MD, PhD, Senior Consultant, Research Group Leader

Karolinska University Hospital

研究点 (1)

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