Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness
NCT07659431, Not yet recruiting, Corporacion Parc Tauli
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness | ClinicalTrials.gov |
| NCT number | NCT07659431 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 114 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Corporacion Parc Tauli | ClinicalTrials.gov |
| Conditions | Post-Intensive Care Syndrome (PICS), Critical Illness | ClinicalTrials.gov |
| First posted | 2026-06-22 | ClinicalTrials.gov |
| Last updated | 2026-06-22 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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 | ClinicalTrials.gov |
| Secondary | Inflammatory phenotypes | Within 24-48 hours of ICU admission | To characterize inflammatory and anti-inflammatory response phenotypes using transcriptomic and biomarker data | ClinicalTrials.gov |
| Secondary | APOE genotype | Within 24-48 hours of ICU admission | To characterize pathological aging mechanisims with APOE genotype | ClinicalTrials.gov |
| Secondary | 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) | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | Sedation treatment | During ICU stay (up to 28 days) | Type of sedative agents administered: * none * propofol * midazolam * remifentanil * dexmedetomidine | ClinicalTrials.gov |
| Secondary | Benzodiazepine use | During ICU stay (up to 28 days) | Recorded as Yes/No | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)