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.
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
- Conditions the study is for
- Post-Intensive Care Syndrome (PICS), Critical Illness
- 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
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- 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.
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 group | Role | What 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.
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)
Inflammatory phenotypes
To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data
Measured: Within 24-48 hours of ICU admission
APOE genotype
To characterize pathological aging mechanisims with APOE genotype
Measured: Within 24-48 hours of ICU admission
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)
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)
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)
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)
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)
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)
Sedation treatment
Type of sedative agents administered:
- none
- propofol
- midazolam
- remifentanil
- dexmedetomidine
Measured: During ICU stay (up to 28 days)
Benzodiazepine use
Recorded as Yes/No
Measured: During ICU stay (up to 28 days)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted22 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care Syndrome (PICS)Studies 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias
- Responsible party
- Principal investigator, Sol Fernandez-Gonzalo, Corporacion Parc Tauli
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Role of Cognitive Reserve, Inflammatory Phenotype and Genetic Vulnerability on Cognitive and Emotional Recovery After Critical Illness
- ClinicalTrials.gov ID
- NCT07659431
- Acronym / sponsor ID
- CORE-ICU / PID2024-160948OA-I00
- Keywords
- Cognitive reserve, cognitive impairment, Inflammation biomarkers, APOE, ICU survivors, Emotional Outcomes, Post-intensive care syndrome (PICS), Critical illness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jun 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients (Parc Taulí Hospital) | – | – |
| Critically ill patients (Hospital Universitario Central de Asturias) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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
Cognitive Reserve
Time frame: 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
27 secondary outcomes
Inflammatory phenotypes
Time frame: Within 24-48 hours of ICU admission
APOE genotype
Time frame: Within 24-48 hours of ICU admission
Level of consciousness
Time frame: During ICU stay (up to 28 days)
Illness severity
Time frame: During ICU stay (up to 28 days)
Comorbidity burden
Time frame: During ICU stay (up to 28 days)
Frailty level
Time frame: During ICU stay (up to 28 days)
Presence of delirium
Time frame: During ICU stay (up to 28 days)
Need and type of mechanical ventilation
Time frame: During ICU stay (up to 28 days)
Sedation treatment
Time frame: During ICU stay (up to 28 days)
Benzodiazepine use
Time frame: During ICU stay (up to 28 days)
Global cognitive function (MoCA)
Time frame: At 3 months and 12 months after ICU discharge
Attention and working memory
Time frame: At 3 months and 12 months after ICU discharge
Verbal memory
Time frame: At 3 months and 12 months after ICU discharge
Processing speed
Time frame: At 3 months and 12 months after ICU discharge
Cognitive flexibility
Time frame: At 3 and 12 months after ICU discharge
Inhibitory control
Time frame: At 3 and 12 months after ICU discharge
Verbal fluency
Time frame: At 3 and 12 months after ICU discharge
Depression
Time frame: At 3 and 12 months after ICU discharge
Anxiety
Time frame: At 3 and 12 months after ICU discharge
Post-traumatic stress disorder
Time frame: At 3 and 12 months after ICU discharge
Perceived cognitive deficits
Time frame: At 3 and 12 months after ICU discharge
Fatigue
Time frame: At 3 and 12 months after ICU discharge
Pain
Time frame: At 3 and 12 months after ICU discharge
Dyspnea
Time frame: At 3 and 12 months after ICU discharge
Sleep quality
Time frame: At 3 and 12 months after ICU discharge
Resilience (post-traumatic growth)
Time frame: At 3 and 12 months after ICU discharge
Quality of life
Time frame: At 3 and 12 months after ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: 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
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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.
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.