Critical IllnessCorti-COGNCT03736135
Cortisol Levels as a Measure of Accumulated Physiological Stress in ICU Patients Undergoing Mechanical Ventilation
An observational study of Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2018to 1 Nov 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients undergoing mechanical ventilation
Who may be able to join
- Critically ill patients with >24hours of mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Critical Illness
- Keywords
- Cortisol, Post-ICU syndrome, Cognitive impairment, Anxiety and depressive symptoms, Mechanical ventilated patients
- Medical subject headings
- Critical Illness, Cognitive Dysfunction, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated physiological stress
Levels of Cortisol in Human Hair (CHH)
Measured: At admission
Accumulated physiological stress
Levels of Cortisol in Human Hair (CHH)
Measured: 1 month after discharge
Accumulated physiological stress
Levels of Cortisol in Human Hair (CHH)
Measured: 1 year after discharge
Secondary outcomes (11)
Delirium
Confusion Assessment Method for ICU(CAM-ICU)
Measured: 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
Charlson comorbidity index
Measured: At ICU admission
Frailty index
Clinical frailty scale of Rockwood (Range 1 to 9 from 'Very fit patient' to ' Terminally ill patient'
Measured: At ICU admission
Post-ICU syndrome physical sequelae
Functional score (Muscle weakness - Grip strength)
Measured: 1 month after discharge
Post-ICU syndrome physical sequelae
Functional score (Muscle weakness - Grip strength)
Measured: 1 year after discharge
Post-ICU syndrome functional sequelae
Functional score (Functional Morbidity - Time Up\&Go)
Measured: 1 month after discharge
Post-ICU syndrome functional sequelae
Functional score (Functional Morbidity - Time Up\&Go)
Measured: 1 year after discharge
Post-ICU syndrome cognitive sequelae
Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)
Measured: 1 month after discharge
Post-ICU syndrome cognitive sequelae
Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)
Measured: 1 year after discharge
Post-ICU syndrome psychological sequelae
Psicological status (Anxiety \& Depression score)
Measured: 1 month after discharge
Post-ICU syndrome psychological sequelae
Psicological status (Anxiety \& Depression score)
Measured: 1year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start30 Nov 2018
- Primary completion30 Jul 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sol Fernandez-Gonzalo, Corporacion Parc Tauli
- Investigators
- Lluís Blanch, PhD, Study director, I3PT-Fundació Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736135
- Sponsor's protocol ID
- CIR2017/032
- Acronym
- Corti-COG
- Status last verified
- Aug 2021
- First submitted
- 22 Oct 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25409903Cuesta 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.
PubMed 22975887Karnatovskaia 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.
PubMed 25449881Pandharipande 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.
PubMed 24088092Hopkins 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.
PubMed 23384320Jackson 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.
PubMed 12682497Reser 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.
PubMed 27334119Liston 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.
PubMed 16870732Allen 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.
PubMed 27986469Hermans 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.
PubMed 19040777Boonen 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.
PubMed 23506003Stalder 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.
PubMed 22366690McLennan 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.
PubMed 26881835
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03736135
- Acronym / sponsor ID
- Corti-COG / CIR2017/032
- Conditions
- Critical Illness
- Keywords
- Cortisol, Post-ICU syndrome, Cognitive impairment, Anxiety and depressive symptoms, Mechanical ventilated patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients undergoing mechanical ventilation
Key inclusion criteria (1 listed)
- Critically ill patients with >24hours of mechanical ventilation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accumulated physiological stress
Time frame: At admission
Levels of Cortisol in Human Hair (CHH)
Accumulated physiological stress
Time frame: 1 month after discharge
Levels of Cortisol in Human Hair (CHH)
Accumulated physiological stress
Time frame: 1 year after discharge
Levels of Cortisol in Human Hair (CHH)
11 secondary outcomes
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
Comorbidity index
Time frame: At ICU admission
Frailty index
Time frame: At ICU admission
Post-ICU syndrome physical sequelae
Time frame: 1 month after discharge
Post-ICU syndrome physical sequelae
Time frame: 1 year after discharge
Post-ICU syndrome functional sequelae
Time frame: 1 month after discharge
Post-ICU syndrome functional sequelae
Time frame: 1 year after discharge
Post-ICU syndrome cognitive sequelae
Time frame: 1 month after discharge
Post-ICU syndrome cognitive sequelae
Time frame: 1 year after discharge
Post-ICU syndrome psychological sequelae
Time frame: 1 month after discharge
Post-ICU syndrome psychological sequelae
Time frame: 1year after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 25409903Berghe GV. Novel insights in the HPA-axis during critical illness. Acta Clin Belg. 2014 Dec;69(6):397-406. doi: 10.1179/2295333714Y.0000000093.
- Background: PubMed 22975887Cuesta 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.
- Background: PubMed 25449881Karnatovskaia 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.
- Background: PubMed 24088092Pandharipande 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.
- Background: PubMed 23384320Hopkins 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.
- Background: PubMed 12682497Jackson 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.
- Background: PubMed 27334119Reser 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.
- Background: PubMed 16870732Liston 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.
- Background: PubMed 27986469Allen 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.
- Background: PubMed 19040777Hermans 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.
- Background: PubMed 23506003Boonen 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.
- Background: PubMed 22366690Stalder 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluís Blanch, PhD study director
I3PT-Fundació Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated physiological stress (time frame: At admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736135, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.