Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorporacion Parc Tauli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
114 Participants
are grouped into 2 trial groupsGroup A: Critically ill patients (Parc Taulí Hospital)
Group B: Critically ill patients (Hospital Universitario Central de Asturias)
Trial outcomes
Primary outcomes
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
Time frame
Within 24-48 hours after ICU dischargeSecondary outcomes
1
Inflammatory phenotypes
To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data
Time frame
Within 24-48 hours of ICU admission2
APOE genotype
To characterize pathological aging mechanisims with APOE genotype
Time frame
Within 24-48 hours of ICU admission3
Level of consciousness
Measured using the Richmond Sedation-Agitation Scale (RASS) Score range: from -5 (unarousable) to +5 (agitated)
Time frame
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
Time frame
During ICU stay (up to 28 days)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Corporacion Parc Tauli
Lead sponsor
Hospital Universitario Central de Asturias
Collaborator
Source ClinicalTrials.gov
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