Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness (CORE-ICU)
Unraveling the Role of Cognitive Reserve, Inflammatory Phenotype and Genetic Vulnerability on Cognitive and Emotional Recovery After Critical Illness
Survivors of critical illness frequently develop persistent cognitive and emotional impairments, known as post-intensive care syndrome (PICS), which substantially impact quality of life and long-term recovery. While prior research has mainly focused on identifying risk factors, the mechanisms underlying resilience to these sequelae remain poorly understood. Emerging evidence suggests that biological factors, including inflammatory responses and genetic vulnerability, together with cognitive reserve, may play a key role in shaping recovery trajectories.
The aim of this multicenter, prospective observational study is to investigate how cognitive reserve, inflammatory phenotype, and genetic profiles interact to influence cognitive and emotional recovery after critical illness. Adult patients will be recruited at Intensive Care Unit (ICU) admission across two centers in Spain. Clinical and sociodemographic data will be collected during the ICU stay, and biological samples obtained early after admission will undergo transcriptomic and genetic analyses. Cognitive and emotional outcomes will be assessed at hospital discharge and at 3 and 12 months post-discharge using standardised neuropsychological and telemedicine-based evaluations.
By integrating clinical, biological, and cognitive data, this study seeks to identify recovery phenotypes and resilience mechanisms in PICS. The results may contribute to improved risk stratification, inform personalized interventions, and support the development of future strategies aimed at reducing the long-term burden of critical illness.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Sol Fernández-Gonzalo, PhD
- Telefonní číslo: +34937236673
- E-mail: msfernandez@tauli.cat
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Adult patients (≥18 years)
- Admitted to a medical-surgical ICU or cardiac ICU for causes of critical illness (e.g., acute pulmonary oedema, myocardial infarction, aortic dissection)
- With or without the need for invasive mechanical ventilation
- With an expected ICU stay of ≥48 hours
- Resident in Catalonia or the Principality of Asturias
- Who speak Catalan and/or Spanish
- Who are able to provide informed consent personally or through an authorised representative (e.g., a family member)
Exclusion Criteria:
- Non-authorisation by the patient and/or relatives for inclusion in the study
- Patients admitted to a neurocritical ICU
- History of severe neurological disease (including dementia or focal brain injury with functional and cognitive impairment) prior to ICU admission
- History of severe psychiatric disorders (schizophrenia, bipolar disorder, major depressive disorder)
- Intellectual disability (IQ <80) or other neurodevelopmental disorders, such as autism spectrum disorder
- Patients who develop secondary complications (e.g., infections, stroke, traumatic brain injury, or other non-transient acquired brain injury) after ICU discharge that may compromise the results of emotional and neuropsychological evaluations during the recovery phase
- Moderate to severe cognitive impairment (Short-IQCODE >57) preventing independent participation in telemedicine or face-to-face follow-up
- Readmission to the ICU within 12 months after ICU discharge
- Language barrier (non-Spanish- and/or non-Catalan-speaking patients)
- Patients with a life expectancy <1 year or not eligible for active treatment measures
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Critically ill patients (Parc Taulí Hospital)
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Critically ill patients (Hospital Universitario Central de Asturias)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cognitive Reserve
Časové okno: Within 24-48 hours after ICU discharge
|
Rami- Cognitive Reserve Questionnaire Score range: 0-25 Cognitive Reserve levels: Low: 0-6 Medium-low: 7-9 Medium-high: 10-14 |
Within 24-48 hours after ICU discharge
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Inflammatory phenotypes
Časové okno: Within 24-48 hours of ICU admission
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To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data
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Within 24-48 hours of ICU admission
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APOE genotype
Časové okno: Within 24-48 hours of ICU admission
|
To characterize pathological aging mechanisims with APOE genotype
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Within 24-48 hours of ICU admission
|
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Level of consciousness
Časové okno: During ICU stay (up to 28 days)
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Measured using the Richmond Sedation-Agitation Scale (RASS) Score range: from -5 (unarousable) to +5 (agitated)
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During ICU stay (up to 28 days)
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Illness severity
Časové okno: During ICU stay (up to 28 days)
|
Assessed using the Sequential Organ Failure Assessment (SOFA) questionnaire Score range: 0-24; 0-6: Mild organ dysfunction 7-9: Moderate severity 10-12: Significant organ dysfunction 13+: Severe illness with substantially increased mortality risk |
During ICU stay (up to 28 days)
|
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Comorbidity burden
Časové okno: During ICU stay (up to 28 days)
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Measured using the Charlson Comorbidity Index (CCI) 0-1 point: Low comorbidity (absence of comorbidities or only very mild diseases). 2-3 points: Moderate to low comorbidity. 4 points or more: Severe comorbidity or high risk. |
During ICU stay (up to 28 days)
|
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Frailty level
Časové okno: During ICU stay (up to 28 days)
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Assessed using the Rockwood Clinical Frailty Scale (CFS) Score range from 0 to 9; 1-3: Fit / Non-frail 4: Vulnerable / Very mild frailty 5: Mild frailty 6: Moderate frailty 7-8: Severe to very severe frailty 9: Terminal illness |
During ICU stay (up to 28 days)
|
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Presence of delirium
Časové okno: During ICU stay (up to 28 days)
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Assessed using the Confusion Assessment Method for the ICU (CAM-ICU) Recorded as Yes/No
|
During ICU stay (up to 28 days)
|
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Need and type of mechanical ventilation
Časové okno: During ICU stay (up to 28 days)
|
Categorised as:
|
During ICU stay (up to 28 days)
|
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Sedation treatment
Časové okno: During ICU stay (up to 28 days)
|
Type of sedative agents administered:
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During ICU stay (up to 28 days)
|
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Benzodiazepine use
Časové okno: During ICU stay (up to 28 days)
|
Recorded as Yes/No
|
During ICU stay (up to 28 days)
|
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Global cognitive function (MoCA)
Časové okno: At 3 months and 12 months after ICU discharge
|
Assessed using the Montreal Cognitive Assessment (MoCA) Score range: 0-30 Interpretation: 26-30 Normal cognitive function 18-25 Mild cognitive impairment (possible) 10-17 Moderate cognitive impairment <10 Severe cognitive impairment |
At 3 months and 12 months after ICU discharge
|
|
Attention and working memory
Časové okno: At 3 months and 12 months after ICU discharge
|
Assessed using Digit Span Forward and Backward (WAIS-IV); Scaled score range: 1-19.
Higher scores indicate better performance; scores <8 suggest impairment.
|
At 3 months and 12 months after ICU discharge
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Verbal memory
Časové okno: At 3 months and 12 months after ICU discharge
|
Assessed using the Rey Auditory Verbal Learning Test (RAVLT); Total score range recall varies (typically 0-75).
Higher scores indicate better verbal learning and memory.
|
At 3 months and 12 months after ICU discharge
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Processing speed
Časové okno: At 3 months and 12 months after ICU discharge
|
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At 3 months and 12 months after ICU discharge
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Cognitive flexibility
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Trail Making Test Part B (TMT-B); measured in seconds.
Lower completion time indicates better performance.
|
At 3 and 12 months after ICU discharge
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Inhibitory control
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Stroop Colour and Word Test.
Higher scores indicate greater impairment in inhibitory control.
|
At 3 and 12 months after ICU discharge
|
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Verbal fluency
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Phonetic Fluency (FAS) Test; measured as the number of words generated.
Higher scores indicate better verbal fluency.
|
At 3 and 12 months after ICU discharge
|
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Depression
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Patient Health Questionnaire-9 (PHQ-9). Score range 0-27; 0-4: None 5-9: Mild 10-14: Moderate 15-19: Moderately severe 20-27: Severe |
At 3 and 12 months after ICU discharge
|
|
Anxiety
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Generalized Anxiety Disorder-7 (GAD-7). Score range 0-21; 0-4: Minimal 5-9: Mild 10-14: Moderate 15-21: Severe |
At 3 and 12 months after ICU discharge
|
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Post-traumatic stress disorder
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Treatment-Outcome Posttraumatic Stress Disorder Scale (TOP-8) Score range 0-32.
Higher scores indicate greater PTSD symptom severity.
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At 3 and 12 months after ICU discharge
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Perceived cognitive deficits
Časové okno: At 3 and 12 months after ICU discharge
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Assessed using the Perceived Deficits Questionnaire (PDQ-D5).
Score range 0-20.
Higher scores indicate greater perceived cognitive impairment.
|
At 3 and 12 months after ICU discharge
|
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Fatigue
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the FACIT Fatigue Scale (FACIT-F).
Score range 0-52.
Lower scores indicate greater fatigue, while higher scores indicate less fatigue.
|
At 3 and 12 months after ICU discharge
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Pain
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Visual Analogue Scale (VAS-10). Score range 0-10; 0: No symptoms 1-3: Mild 4-6: Moderate 7-10: Severe |
At 3 and 12 months after ICU discharge
|
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Dyspnea
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Visual Analogue Scale (VAS-10). Score range 0-10; 0: No symptoms 1-3: Mild 4-6: Moderate 7-10: Severe |
At 3 and 12 months after ICU discharge
|
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Sleep quality
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the Pittsburgh Sleep Quality Index (PSQI).
Score range 0-21.
Scores >5 indicate poor sleep quality.
|
At 3 and 12 months after ICU discharge
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Resilience (post-traumatic growth)
Časové okno: At 3 and 12 months after ICU discharge
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Assessed using the Posttraumatic Growth Inventory (PTGI).
Score range 0-105.
Higher scores indicate greater post-traumatic growth.
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At 3 and 12 months after ICU discharge
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Quality of life
Časové okno: At 3 and 12 months after ICU discharge
|
Assessed using the 12-Item Short Form Health Survey (SF-12).
Score range 0-100.
Higher scores indicate better health-related quality of life.
|
At 3 and 12 months after ICU discharge
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PID2024-160948OA-I00
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The data generated will be deposited in recognized open access repositories, accompanied by clear and standardized metadata, which will facilitate its discovery and reuse by other researchers (Institutional reference repository: CORA https://dataverse.csuc.cat/).
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