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Cortisol Levels as a Measure of Accumulated Physiological Stress in ICU Patients Undergoing Mechanical Ventilation (Corti-COG)

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ClinicalTrials.gov Identifier: NCT03736135
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sol Fernandez-Gonzalo, 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.


Condition or disease
Critical Illness

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 Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official 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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : November 1, 2020





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients undergoing mechanical ventilation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736135


Contacts
Contact: Sol Fernandez-Gonzalo, PhD +34 93 723 10 10 ext 22065 msfernandez@tauli.cat

Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Study Director: Lluís Blanch, PhD I3PT-Fundació Parc Taulí

Publications:

Responsible Party: Sol Fernandez-Gonzalo, Principal Investigator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03736135     History of Changes
Other Study ID Numbers: CIR2017/032
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sol Fernandez-Gonzalo, Corporacion Parc Tauli:
Cortisol
Post-ICU syndrome
Cognitive impairment
Anxiety and depressive symptoms
Mechanical ventilated patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents