跳至主要内容
临床试验/NCT03736135
NCT03736135已完成不适用

Cortisol Levels as a Measure of Accumulated Physiological Stress in Mechanical Ventilated ICU Patients: the Relationship With Premorbid Frailty, Functional, Cognitive and Psychopathological Impairment in the ICU Survivors

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Accumulated physiological stress

研究概览

简要总结

Critical illness is a situation of severe and prolonged stress for patients with mechanical ventilation (MV). Between 40-80% of these patients present the Post-ICU syndrome, a set of physical, cognitive, psychological alterations at hospital discharge. In more than a third of the ICU survivors, these sequelae become chronic being observed months and even years after ICU stay.

The characteristics of the Post-ICU syndrome have been related to different risk factors associated with the critical illness and its management. However, the impact of accumulated physiological stress is still unknown. The physiological response to prolonged stress generates high levels of cortisol that have been related to the loss of muscle tissue, cognitive and psychological alterations in both clinical populations and healthy subjects. The concentration of cortisol in plasma is not a measure of adequate physiological stress due to the dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis during critical illness. Therefore, the objective of this study is to assess the levels of accumulated cortisol in human hair (CHH) during the different stages of the critical illness and its recovery, as well as to explore its relationship with the functional and neuropsychological sequelae observed in the ICU survivors.

详细描述

A prospective pilot study has been proposed in 50 critical patients with> 24 hours of mechanical ventilation. CHH levels will be recorded at admission, 1 month and 1 year after ICU discharge. In all survivors, the presence of delirium will be assessed during the ICU stay and the functional, cognitive and psychological status will be assessed at short (1 month after ICU discharge) and long term (1 year after ICU discharge).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill patients with >24hours of mechanical ventilation

排除标准

  • Previous neurological and/or psychiatric pathology
  • Sensory alterations that prevent the application of the neurocognitive tests
  • Cognitive impairment prior to ICU admission (Score >57 in the Short Form of the Informant Questionnaire on Cognitive. Decline -Short IQCODE-)
  • Sever alopecia
  • Rejection of voluntary participation

结局指标

主要结局

Accumulated physiological stress

时间窗: 1 year after discharge

Levels of Cortisol in Human Hair (CHH)

次要结局

  • Comorbidity index(At ICU admission)
  • Post-ICU syndrome physical sequelae(1 year after discharge)
  • Delirium(From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 months)
  • Post-ICU syndrome cognitive sequelae(1 year after discharge)
  • Post-ICU syndrome psychological sequelae(1year after discharge)
  • Frailty index(At ICU admission)
  • Post-ICU syndrome functional sequelae(1 year after discharge)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sol Fernandez-Gonzalo

Principal Investigator

Corporacion Parc Tauli

研究点 (1)

Loading locations...

相似试验