Immunological and inflammation markers linked to ICU patient outcomes
Studies on the Immunological and Inflammatory Determinants Associated With the Prognosis of Patients Admitted to Intensive Care
Assistance Publique - Hôpitaux de Paris · NCT07345169
This study will try to see if certain immune and inflammation markers taken from adults admitted to intensive care can predict one-year survival and the risk of hospital-acquired infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT07345169 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling adults admitted to the ICU within 24 hours to collect routine and minimal extra blood samples for immune and inflammatory biomarker analysis. Samples are taken at admission, day 1, day 4, day 8, at ICU discharge or day 28, and again at 12 months, with additional sampling during major clinical events such as nosocomial infections. The data will be used to build multidimensional models predicting one-year survival and the occurrence of hospital-acquired infections. Patients with pre-existing immunosuppression, pregnant or breastfeeding women, moribund patients, uninsured people, and those under legal protection are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are admitted to the ICU within 24 hours and do not have pre-existing immunosuppression, pregnancy, legal protection status, or participation in another interventional trial.
Not a fit: Patients unlikely to benefit include those with active or recent immunosuppression, moribund patients, uninsured individuals, pregnant or breastfeeding women, and people under guardianship or curatorship, who are excluded from the protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians identify ICU patients at higher risk of death or infection earlier so care and monitoring can be tailored.
How similar studies have performed: Previous observational work has linked immune and inflammatory markers to outcomes in sepsis and critical illness, but predictive models remain variable and this study seeks to improve them with longitudinal sampling.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Admission to ICU within 24 hours Exclusion Criteria: * Moribund patient (ECOG=4) * Legal protection (guardianship/curatorship) * Uninsured patients * Pre-existing immunosuppression (active/recent cancer, hematologic disease, autoimmune disease, organ transplant, HIV) * Pregnant or breastfeeding women * Participation in another interventional trial * Patients under AME
Where this trial is running
Paris
- AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Charles de de Roquetaillade, MD
- Email: charles.de-roquetaillade@aphp.fr
- Phone: +33 1 49 95 85 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Intensive Care Patients, Critical Illness Requiring Intensive Care - Sepsis, Critical Illness Requiring Intensive Care - Acute Brain Injury, Critical Illness Requiring Intensive Care - Major Surgery, Critical Illness Requiring Intensive Care - Polytrauma, Sepsis, Critical illness