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Post-Intensive Care Syndrome (PICS)CORE-ICUNCT07659431

Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness

An observational study of Post-Intensive Care Syndrome (PICS) and Critical Illness, run by Corporacion Parc Tauli.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
114 participants
Where
No sites listed yet
Study dates
Jul 2026to Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sol Fernández-Gonzalo, PhD contact

+34937236673

msfernandez@tauli.cat

About this study

Official title: 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.

Keywords
Cognitive reserve, cognitive impairment, Inflammation biomarkers, APOE, ICU survivors, Emotional Outcomes, Post-intensive care syndrome (PICS), Critical illness
Medical subject headings
postintensive care syndrome, Critical Illness, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07659431
Study groupRoleWhat they receive
Critically ill patients (Parc Taulí Hospital)Not described
Critically ill patients (Hospital Universitario Central de Asturias)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Reserve

    Rami- Cognitive Reserve Questionnaire Score range: 0-25

    Cognitive Reserve levels:

    Low: 0-6 Medium-low: 7-9 Medium-high: 10-14

    Measured: Within 24-48 hours after ICU discharge

Secondary outcomes (27)
  1. Inflammatory phenotypes

    To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data

    Measured: Within 24-48 hours of ICU admission

  2. APOE genotype

    To characterize pathological aging mechanisims with APOE genotype

    Measured: Within 24-48 hours of ICU admission

  3. Level of consciousness

    Measured using the Richmond Sedation-Agitation Scale (RASS) Score range: from -5 (unarousable) to +5 (agitated)

    Measured: During ICU stay (up to 28 days)

  4. Illness severity

    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

    Measured: During ICU stay (up to 28 days)

  5. Comorbidity burden

    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.

    Measured: During ICU stay (up to 28 days)

  6. Frailty level

    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

    Measured: During ICU stay (up to 28 days)

  7. Presence of delirium

    Assessed using the Confusion Assessment Method for the ICU (CAM-ICU) Recorded as Yes/No

    Measured: During ICU stay (up to 28 days)

  8. Need and type of mechanical ventilation

    Categorised as:

    • no mechanical ventilation
    • invasive mechanical ventilation
    • high-flow oxygen therapy
    • non-invasive mechanical ventilation

    Measured: During ICU stay (up to 28 days)

  9. Sedation treatment

    Type of sedative agents administered:

    • none
    • propofol
    • midazolam
    • remifentanil
    • dexmedetomidine

    Measured: During ICU stay (up to 28 days)

  10. Benzodiazepine use

    Recorded as Yes/No

    Measured: During ICU stay (up to 28 days)

  11. Global cognitive function (MoCA)

    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

    Measured: At 3 months and 12 months after ICU discharge

  12. Attention and working memory

    Assessed using Digit Span Forward and Backward (WAIS-IV); Scaled score range: 1-19. Higher scores indicate better performance; scores <8 suggest impairment.

    Measured: At 3 months and 12 months after ICU discharge

  13. Verbal memory

    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.

    Measured: At 3 months and 12 months after ICU discharge

  14. Processing speed

    • 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.

    Measured: At 3 months and 12 months after ICU discharge

  15. Cognitive flexibility

    Assessed using the Trail Making Test Part B (TMT-B); measured in seconds. Lower completion time indicates better performance.

    Measured: At 3 and 12 months after ICU discharge

  16. Inhibitory control

    Assessed using the Stroop Colour and Word Test. Higher scores indicate greater impairment in inhibitory control.

    Measured: At 3 and 12 months after ICU discharge

  17. Verbal fluency

    Assessed using the Phonetic Fluency (FAS) Test; measured as the number of words generated. Higher scores indicate better verbal fluency.

    Measured: At 3 and 12 months after ICU discharge

  18. Depression

    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

    Measured: At 3 and 12 months after ICU discharge

  19. Anxiety

    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

    Measured: At 3 and 12 months after ICU discharge

  20. Post-traumatic stress disorder

    Assessed using the Treatment-Outcome Posttraumatic Stress Disorder Scale (TOP-8) Score range 0-32. Higher scores indicate greater PTSD symptom severity.

    Measured: At 3 and 12 months after ICU discharge

  21. Perceived cognitive deficits

    Assessed using the Perceived Deficits Questionnaire (PDQ-D5). Score range 0-20. Higher scores indicate greater perceived cognitive impairment.

    Measured: At 3 and 12 months after ICU discharge

  22. Fatigue

    Assessed using the FACIT Fatigue Scale (FACIT-F). Score range 0-52. Lower scores indicate greater fatigue, while higher scores indicate less fatigue.

    Measured: At 3 and 12 months after ICU discharge

  23. Pain

    Assessed using the Visual Analogue Scale (VAS-10).

    Score range 0-10;

    0: No symptoms 1-3: Mild 4-6: Moderate 7-10: Severe

    Measured: At 3 and 12 months after ICU discharge

  24. Dyspnea

    Assessed using the Visual Analogue Scale (VAS-10).

    Score range 0-10;

    0: No symptoms 1-3: Mild 4-6: Moderate 7-10: Severe

    Measured: At 3 and 12 months after ICU discharge

  25. Sleep quality

    Assessed using the Pittsburgh Sleep Quality Index (PSQI). Score range 0-21. Scores >5 indicate poor sleep quality.

    Measured: At 3 and 12 months after ICU discharge

  26. Resilience (post-traumatic growth)

    Assessed using the Posttraumatic Growth Inventory (PTGI). Score range 0-105. Higher scores indicate greater post-traumatic growth.

    Measured: At 3 and 12 months after ICU discharge

  27. Quality of life

    Assessed using the 12-Item Short Form Health Survey (SF-12). Score range 0-100. Higher scores indicate better health-related quality of life.

    Measured: At 3 and 12 months after ICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07659431
Sponsor's protocol ID
PID2024-160948OA-I00
Acronym
CORE-ICU
Status last verified
Jun 2026
First submitted
28 May 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Post-Intensive Care Syndrome (PICS) and Critical Illness, run by Corporacion Parc Tauli.

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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sol Fernández-Gonzalo, PhD (+34937236673, msfernandez@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Reserve (time frame: Within 24-48 hours after ICU discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Jun 2026.

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