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

Critical Illness Clinical Trial

— Corti-COG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736135
• Other study ID #: CIR2017/032
• Status: Completed
• Start date: November 30, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2021
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 1, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Spain	Fundacio Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Allen AP, Curran EA, Duggan Á, Cryan JF, Chorcoráin 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. Review. — View Citation

Berghe GV. Novel insights in the HPA-axis during critical illness. Acta Clin Belg. 2014 Dec;69(6):397-406. doi: 10.1179/2295333714Y.0000000093. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Illness severity	Acute Physiology and Chronic Health Evaluation (APACHE II)	At ICU admission
Other	Days of MV	Time with mechanical ventilation	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
Other	ICU stay	Days in ICU	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
Other	Hospital stay	Days in hospital after ICU discharge	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
Other	Level of f alertness or agitation	Richmond Agitation-Sedation Scale (RASS)	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
Other	Dosis of sedatives and opioids	Daily accumulated dosis of sedatives and opioids	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
Primary	Accumulated physiological stress	Levels of Cortisol in Human Hair (CHH)	At admission
Primary	Accumulated physiological stress	Levels of Cortisol in Human Hair (CHH)	1 month after discharge
Primary	Accumulated physiological stress	Levels of Cortisol in Human Hair (CHH)	1 year after discharge
Secondary	Delirium	Confusion Assessment Method for ICU(CAM-ICU)	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
Secondary	Comorbidity index	Charlson comorbidity index	At ICU admission
Secondary	Frailty index	Clinical frailty scale of Rockwood (Range 1 to 9 from 'Very fit patient' to ' Terminally ill patient'	At ICU admission
Secondary	Post-ICU syndrome physical sequelae	Functional score (Muscle weakness - Grip strength)	1 month after discharge
Secondary	Post-ICU syndrome physical sequelae	Functional score (Muscle weakness - Grip strength)	1 year after discharge
Secondary	Post-ICU syndrome functional sequelae	Functional score (Functional Morbidity - Time Up&Go)	1 month after discharge
Secondary	Post-ICU syndrome functional sequelae	Functional score (Functional Morbidity - Time Up&Go)	1 year after discharge
Secondary	Post-ICU syndrome cognitive sequelae	Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)	1 month after discharge
Secondary	Post-ICU syndrome cognitive sequelae	Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)	1 year after discharge
Secondary	Post-ICU syndrome psychological sequelae	Psicological status (Anxiety & Depression score)	1 month after discharge
Secondary	Post-ICU syndrome psychological sequelae	Psicological status (Anxiety & Depression score)	1year after discharge