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

Completed

• Conditions: Critical Illness

• Registration Number: NCT03736135
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Study Start: 2018-11-30
• Primary Completion: 2020-07-30
• Study Completion: 2020-11-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accumulated physiological stress	1 year after discharge	Levels of Cortisol in Human Hair (CHH)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fundacio Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain