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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03736135
Acronym
Corti-COG
Enrollment
26
Registered
2018-11-08
Start date
2018-11-30
Completion date
2020-11-01
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Cortisol, Post-ICU syndrome, Cognitive impairment, Anxiety and depressive symptoms, Mechanical ventilated patients

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).

Interventions

None listed

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accumulated physiological stressAt admissionLevels of Cortisol in Human Hair (CHH)

Secondary

MeasureTime frameDescription
Post-ICU syndrome psychological sequelae1 month after dischargePsicological status (Anxiety & Depression score)
DeliriumFrom date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 monthsConfusion Assessment Method for ICU(CAM-ICU)
Comorbidity indexAt ICU admissionCharlson comorbidity index
Frailty indexAt ICU admissionClinical frailty scale of Rockwood (Range 1 to 9 from 'Very fit patient' to ' Terminally ill patient'
Post-ICU syndrome physical sequelae1 month after dischargeFunctional score (Muscle weakness - Grip strength)
Post-ICU syndrome functional sequelae1 month after dischargeFunctional score (Functional Morbidity - Time Up&Go)
Post-ICU syndrome cognitive sequelae1 month after dischargeNeurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)

Other

MeasureTime frameDescription
ICU stayFrom date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 monthsDays in ICU
Hospital stayFrom date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 monthsDays in hospital after ICU discharge
Level of f alertness or agitationFrom date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 monthsRichmond Agitation-Sedation Scale (RASS)
Dosis of sedatives and opioidsFrom date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 monthsDaily accumulated dosis of sedatives and opioids
Days of MVFrom date of intubation in ICU until the date of extubation in ICU or date of death from any cause, whichever came first, assessed up to 3 monthsTime with mechanical ventilation
Illness severityAt ICU admissionAcute Physiology and Chronic Health Evaluation (APACHE II)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026