Critical Illness, Post-Intensive Care Syndrome (PICS)
Conditions
Keywords
Cognitive reserve, cognitive impairment, Inflammation biomarkers, APOE, ICU survivors, Emotional Outcomes, Post-intensive care syndrome (PICS), Critical illness
Brief 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. 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.
Interventions
None listed
Sponsors
Corporacion Parc Tauli
Hospital Universitario Central de Asturias
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Reserve | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory phenotypes | Within 24-48 hours of ICU admission | To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data |
| APOE genotype | Within 24-48 hours of ICU admission | To characterize pathological aging mechanisims with APOE genotype |
| Level of consciousness | During ICU stay (up to 28 days) | Measured using the Richmond Sedation-Agitation Scale (RASS) Score range: from -5 (unarousable) to +5 (agitated) |
| Illness severity | 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 |
| Comorbidity burden | 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. |
| Frailty level | 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 |
| Presence of delirium | During ICU stay (up to 28 days) | Assessed using the Confusion Assessment Method for the ICU (CAM-ICU) Recorded as Yes/No |
| Need and type of mechanical ventilation | During ICU stay (up to 28 days) | Categorised as: * no mechanical ventilation * invasive mechanical ventilation * high-flow oxygen therapy * non-invasive mechanical ventilation |
| Sedation treatment | During ICU stay (up to 28 days) | Type of sedative agents administered: * none * propofol * midazolam * remifentanil * dexmedetomidine |
| Benzodiazepine use | During ICU stay (up to 28 days) | Recorded as Yes/No |
| Global cognitive function (MoCA) | 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 |
| Attention and working memory | 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. |
| Verbal memory | 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. |
| Processing speed | 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. |
| Cognitive flexibility | 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. |
| Inhibitory control | At 3 and 12 months after ICU discharge | Assessed using the Stroop Colour and Word Test. Higher scores indicate greater impairment in inhibitory control. |
| Verbal fluency | 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. |
| Depression | 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 |
| Anxiety | 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 |
| Post-traumatic stress disorder | 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. |
| Perceived cognitive deficits | 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. |
| Fatigue | 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. |
| Pain | 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 |
| Dyspnea | 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 |
| Sleep quality | 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. |
| Resilience (post-traumatic growth) | 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. |
| Quality of life | 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. |
Contacts
CONTACTSol Fernández-Gonzalo, PhD
Outcome results
None listed