Cortisol Levels as a Measure of Accumulated Physiological Stress in ICU Patients Undergoing Mechanical Ventilation (Corti-COG)
3 de agosto de 2021 actualizado por: Sol Fernandez-Gonzalo, Corporacion Parc Tauli
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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).
Tipo de estudio
De observación
Inscripción (Actual)
26
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Barcelona
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Sabadell, Barcelona, España, 08208
- Fundacio Parc Tauli
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Critically ill patients undergoing mechanical ventilation
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accumulated physiological stress
Periodo de tiempo: At admission
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Levels of Cortisol in Human Hair (CHH)
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At admission
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Accumulated physiological stress
Periodo de tiempo: 1 month after discharge
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Levels of Cortisol in Human Hair (CHH)
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1 month after discharge
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Accumulated physiological stress
Periodo de tiempo: 1 year after discharge
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Levels of Cortisol in Human Hair (CHH)
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1 year after discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Delirium
Periodo de tiempo: 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
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Confusion Assessment Method for ICU(CAM-ICU)
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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
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Comorbidity index
Periodo de tiempo: At ICU admission
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Charlson comorbidity index
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At ICU admission
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Frailty index
Periodo de tiempo: At ICU admission
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Clinical frailty scale of Rockwood (Range 1 to 9 from 'Very fit patient' to ' Terminally ill patient'
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At ICU admission
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Post-ICU syndrome physical sequelae
Periodo de tiempo: 1 month after discharge
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Functional score (Muscle weakness - Grip strength)
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1 month after discharge
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Post-ICU syndrome physical sequelae
Periodo de tiempo: 1 year after discharge
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Functional score (Muscle weakness - Grip strength)
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1 year after discharge
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Post-ICU syndrome functional sequelae
Periodo de tiempo: 1 month after discharge
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Functional score (Functional Morbidity - Time Up&Go)
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1 month after discharge
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Post-ICU syndrome functional sequelae
Periodo de tiempo: 1 year after discharge
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Functional score (Functional Morbidity - Time Up&Go)
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1 year after discharge
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Post-ICU syndrome cognitive sequelae
Periodo de tiempo: 1 month after discharge
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Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)
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1 month after discharge
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Post-ICU syndrome cognitive sequelae
Periodo de tiempo: 1 year after discharge
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Neurocognitive score (Neurocognitive Indexes based in the neuropsychological tests)
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1 year after discharge
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Post-ICU syndrome psychological sequelae
Periodo de tiempo: 1 month after discharge
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Psicological status (Anxiety & Depression score)
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1 month after discharge
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Post-ICU syndrome psychological sequelae
Periodo de tiempo: 1year after discharge
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Psicological status (Anxiety & Depression score)
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1year after discharge
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Illness severity
Periodo de tiempo: At ICU admission
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Acute Physiology and Chronic Health Evaluation (APACHE II)
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At ICU admission
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Days of MV
Periodo de tiempo: 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
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Time with mechanical ventilation
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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
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ICU stay
Periodo de tiempo: 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
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Days in ICU
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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
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Hospital stay
Periodo de tiempo: 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
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Days in hospital after ICU discharge
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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
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Level of f alertness or agitation
Periodo de tiempo: 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
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Richmond Agitation-Sedation Scale (RASS)
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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
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Dosis of sedatives and opioids
Periodo de tiempo: 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
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Daily accumulated dosis of sedatives and opioids
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Lluís Blanch, PhD, I3PT-Fundació Parc Taulí
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de noviembre de 2018
Finalización primaria (Actual)
30 de julio de 2020
Finalización del estudio (Actual)
1 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
22 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
7 de noviembre de 2018
Publicado por primera vez (Actual)
8 de noviembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIR2017/032
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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