Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Post-Intensive Care Syndrome (PICS), Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Unraveling the Role of Cognitive Reserve, Inflammatory Phenotype and Genetic Vulnerability on Cognitive and Emotional Recovery After Critical Illness
Overview
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.
Primary outcome measures
- Cognitive Reserve [Time frame: Within 24-48 hours after ICU discharge]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07659431 · PID2024-160948OA-I00