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Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness (CORE-ICU)

16. juni 2026 opdateret af: Sol Fernandez-Gonzalo, Corporacion Parc Tauli

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

114

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Critically ill patients admitted to the medical / post-surgical ICU of the Parc Tauli Hospital (Sabadell, Spain), and to the Hospital Universitario Central de Asturias.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Critically ill patients (Parc Taulí Hospital)
Critically ill patients (Hospital Universitario Central de Asturias)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Reserve
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inflammatory phenotypes
Tidsramme: Within 24-48 hours of ICU admission
To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data
Within 24-48 hours of ICU admission
APOE genotype
Tidsramme: Within 24-48 hours of ICU admission
To characterize pathological aging mechanisims with APOE genotype
Within 24-48 hours of ICU admission
Level of consciousness
Tidsramme: During ICU stay (up to 28 days)
Measured using the Richmond Sedation-Agitation Scale (RASS) Score range: from -5 (unarousable) to +5 (agitated)
During ICU stay (up to 28 days)
Illness severity
Tidsramme: 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)
Comorbidity burden
Tidsramme: During ICU stay (up to 28 days)

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)
Frailty level
Tidsramme: During ICU stay (up to 28 days)

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)
Presence of delirium
Tidsramme: During ICU stay (up to 28 days)
Assessed using the Confusion Assessment Method for the ICU (CAM-ICU) Recorded as Yes/No
During ICU stay (up to 28 days)
Need and type of mechanical ventilation
Tidsramme: During ICU stay (up to 28 days)

Categorised as:

  • no mechanical ventilation
  • invasive mechanical ventilation
  • high-flow oxygen therapy
  • non-invasive mechanical ventilation
During ICU stay (up to 28 days)
Sedation treatment
Tidsramme: During ICU stay (up to 28 days)

Type of sedative agents administered:

  • none
  • propofol
  • midazolam
  • remifentanil
  • dexmedetomidine
During ICU stay (up to 28 days)
Benzodiazepine use
Tidsramme: During ICU stay (up to 28 days)
Recorded as Yes/No
During ICU stay (up to 28 days)
Global cognitive function (MoCA)
Tidsramme: 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
Tidsramme: 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
Verbal memory
Tidsramme: 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
Processing speed
Tidsramme: At 3 months and 12 months after ICU discharge
  • Assessed using Coding (WAIS-IV); Scaled score range 1-19. Higher scores indicate better processing speed; scores <8 suggest impairment.
  • Assessed using the Symbol Digit Modalities Test (SDMT); Higher scores indicate better processing speed.
At 3 months and 12 months after ICU discharge
Cognitive flexibility
Tidsramme: 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
Inhibitory control
Tidsramme: 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
Verbal fluency
Tidsramme: 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
Depression
Tidsramme: 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
Tidsramme: 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
Post-traumatic stress disorder
Tidsramme: 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.
At 3 and 12 months after ICU discharge
Perceived cognitive deficits
Tidsramme: At 3 and 12 months after ICU discharge
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
Fatigue
Tidsramme: 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
Pain
Tidsramme: 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
Dyspnea
Tidsramme: 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
Sleep quality
Tidsramme: 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
Resilience (post-traumatic growth)
Tidsramme: At 3 and 12 months after ICU discharge
Assessed using the Posttraumatic Growth Inventory (PTGI). Score range 0-105. Higher scores indicate greater post-traumatic growth.
At 3 and 12 months after ICU discharge
Quality of life
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Corporacion Parc Tauli

Samarbejdspartnere

Hospital Universitario Central de Asturias

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PID2024-160948OA-I00

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

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/).

These measures not only ensure responsible treatment of data, but also guarantee their reuse and control

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