Cortisol Levels as a Measure of Accumulated Physiological Stress in ICU Patients Undergoing Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Critical Illness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients with >24hours of mechanical ventilation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulated physiological stress | Levels of Cortisol in Human Hair (CHH) | At admission | 
| Accumulated physiological stress | Levels of Cortisol in Human Hair (CHH) | 1 month after discharge | 
| Accumulated physiological stress | Levels of Cortisol in Human Hair (CHH) | 1 year after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Confusion Assessment Method for ICU(CAM-ICU) | 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 | 
| Comorbidity index | Charlson comorbidity index | At ICU admission | 
| Frailty index | Clinical frailty scale of Rockwood (Range 1 to 9 from 'Very fit patient' to ' Terminally ill patient' | At ICU admission | 
| Post-ICU syndrome physical sequelae | Functional score (Muscle weakness - Grip strength) | 1 month after discharge | 
| Post-ICU syndrome physical sequelae | Functional score (Muscle weakness - Grip strength) | 1 year after discharge | 
| Post-ICU syndrome functional sequelae | Functional score (Functional Morbidity - Time Up&Go) | 1 month after discharge | 
| Post-ICU syndrome functional sequelae | Functional score (Functional Morbidity - Time Up&Go) | 1 year after discharge | 
| Post-ICU syndrome cognitive sequelae | Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests) | 1 month after discharge | 
| Post-ICU syndrome cognitive sequelae | Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests) | 1 year after discharge | 
| Post-ICU syndrome psychological sequelae | Psicological status (Anxiety & Depression score) | 1 month after discharge | 
| Post-ICU syndrome psychological sequelae | Psicological status (Anxiety & Depression score) | 1year after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-ICU syndrome, Cognitive impairment, Anxiety and depressive symptoms, Mechanical ventilated patients, Cortisol