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

NCT03736135 | Completed

• 1 other identifier: CIR2017/032
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

• Comorbidity index

  At ICU admission

• Frailty index

  At ICU admission

• Post-ICU syndrome physical sequelae

  1 month after discharge

• Post-ICU syndrome physical sequelae

  1 year after discharge

Other Outcomes (6)

• Illness severity

  At ICU admission

• Days of MV

  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

• ICU stay

  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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients undergoing mechanical ventilation

You may qualify if:

• Critically ill patients with \>24hours of mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Fundacio Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (13)

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  PMID: 25409903 BACKGROUND

• Cuesta JM, Singer M. The stress response and critical illness: a review. Crit Care Med. 2012 Dec;40(12):3283-9. doi: 10.1097/CCM.0b013e31826567eb.

  PMID: 22975887 BACKGROUND

• Karnatovskaia LV, Johnson MM, Benzo RP, Gajic O. The spectrum of psychocognitive morbidity in the critically ill: a review of the literature and call for improvement. J Crit Care. 2015 Feb;30(1):130-7. doi: 10.1016/j.jcrc.2014.09.024. Epub 2014 Oct 2.

  PMID: 25449881 BACKGROUND

• Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

  PMID: 24088092 BACKGROUND

• Hopkins RO. The brain after critical illness: effect of illness and aging on cognitive function. Crit Care. 2013 Feb 6;17(1):116. doi: 10.1186/cc11913.

  PMID: 23384320 BACKGROUND

• Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, Ely EW. Six-month neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003 Apr;31(4):1226-34. doi: 10.1097/01.CCM.0000059996.30263.94.

  PMID: 12682497 BACKGROUND

• Reser JE. Chronic stress, cortical plasticity and neuroecology. Behav Processes. 2016 Aug;129:105-115. doi: 10.1016/j.beproc.2016.06.010. Epub 2016 Jun 19.

  PMID: 27334119 BACKGROUND

• Liston C, Miller MM, Goldwater DS, Radley JJ, Rocher AB, Hof PR, Morrison JH, McEwen BS. Stress-induced alterations in prefrontal cortical dendritic morphology predict selective impairments in perceptual attentional set-shifting. J Neurosci. 2006 Jul 26;26(30):7870-4. doi: 10.1523/JNEUROSCI.1184-06.2006.

  PMID: 16870732 BACKGROUND

• Allen AP, Curran EA, Duggan A, Cryan JF, Chorcorain AN, Dinan TG, Molloy DW, Kearney PM, Clarke G. A systematic review of the psychobiological burden of informal caregiving for patients with dementia: Focus on cognitive and biological markers of chronic stress. Neurosci Biobehav Rev. 2017 Feb;73:123-164. doi: 10.1016/j.neubiorev.2016.12.006. Epub 2016 Dec 13.

  PMID: 27986469 BACKGROUND

• Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Clinical review: Critical illness polyneuropathy and myopathy. Crit Care. 2008;12(6):238. doi: 10.1186/cc7100. Epub 2008 Nov 25.

  PMID: 19040777 BACKGROUND

• Boonen E, Vervenne H, Meersseman P, Andrew R, Mortier L, Declercq PE, Vanwijngaerden YM, Spriet I, Wouters PJ, Vander Perre S, Langouche L, Vanhorebeek I, Walker BR, Van den Berghe G. Reduced cortisol metabolism during critical illness. N Engl J Med. 2013 Apr 18;368(16):1477-88. doi: 10.1056/NEJMoa1214969. Epub 2013 Mar 19.

  PMID: 23506003 BACKGROUND

• Stalder T, Kirschbaum C. Analysis of cortisol in hair--state of the art and future directions. Brain Behav Immun. 2012 Oct;26(7):1019-29. doi: 10.1016/j.bbi.2012.02.002. Epub 2012 Feb 15.

  PMID: 22366690 BACKGROUND

• McLennan SN, Ihle A, Steudte-Schmiedgen S, Kirschbaum C, Kliegel M. Hair cortisol and cognitive performance in working age adults. Psychoneuroendocrinology. 2016 May;67:100-3. doi: 10.1016/j.psyneuen.2016.01.029. Epub 2016 Feb 1.

  PMID: 26881835 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Cognitive Dysfunction; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lluís Blanch, PhD

  I3PT-Fundació Parc Taulí

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 8, 2018
• Study Start: November 30, 2018
• Primary Completion: July 30, 2020
• Study Completion: November 1, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

ES (1)