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Completed

NCT Number: NCT03736135

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

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.

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Key information

Conditions

Critical Illness Anxiety Disorders Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Depression Disease Attributes Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacio Parc Taulí

Sabadell, Barcelona, 08208, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Accumulated physiological stress

    Time frame: At admission

    Levels of Cortisol in Human Hair (CHH)

  2. Accumulated physiological stress

    Time frame: 1 month after discharge

    Levels of Cortisol in Human Hair (CHH)

  3. Accumulated physiological stress

    Time frame: 1 year after discharge

    Levels of Cortisol in Human Hair (CHH)

Secondary outcomes

  1. Delirium

    Time frame: 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)

  2. Comorbidity index

    Time frame: At ICU admission

    Charlson comorbidity index

  3. Frailty index

    Time frame: At ICU admission

    Clinical frailty scale of Rockwood (Range 1 to 9 from 'Very fit patient' to ' Terminally ill patient'

  4. Post-ICU syndrome physical sequelae

    Time frame: 1 month after discharge

    Functional score (Muscle weakness - Grip strength)

  5. Post-ICU syndrome physical sequelae

    Time frame: 1 year after discharge

    Functional score (Muscle weakness - Grip strength)

  6. Post-ICU syndrome functional sequelae

    Time frame: 1 month after discharge

    Functional score (Functional Morbidity - Time Up&Go)

  7. Post-ICU syndrome functional sequelae

    Time frame: 1 year after discharge

    Functional score (Functional Morbidity - Time Up&Go)

  8. Post-ICU syndrome cognitive sequelae

    Time frame: 1 month after discharge

    Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)

  9. Post-ICU syndrome cognitive sequelae

    Time frame: 1 year after discharge

    Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)

  10. Post-ICU syndrome psychological sequelae

    Time frame: 1 month after discharge

    Psicological status (Anxiety & Depression score)

  11. Post-ICU syndrome psychological sequelae

    Time frame: 1year after discharge

    Psicological status (Anxiety & Depression score)

Other outcomes

  1. Illness severity

    Time frame: At ICU admission

    Acute Physiology and Chronic Health Evaluation (APACHE II)

  2. Days of MV

    Time frame: From 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 months

    Time with mechanical ventilation

  3. ICU stay

    Time frame: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 months

    Days in ICU

  4. Hospital stay

    Time frame: From date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months

    Days in hospital after ICU discharge

  5. Level of f alertness or agitation

    Time frame: 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

    Richmond Agitation-Sedation Scale (RASS)

  6. Dosis of sedatives and opioids

    Time frame: 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

    Daily accumulated dosis of sedatives and opioids

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Acronym: Corti-COG

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2018
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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