Predicting mortality risk for people 75 and older admitted to the ICU.
Development of a Predictive Model for Mortality in Patients Aged 75 or Older With Critical Illness
This project tries to use lab biomarker data to predict which people aged 75 and older admitted from the emergency department to the ICU are most likely to die.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 15 sites (Badalona, Barcelona and 14 other locations) |
| Trial ID | NCT06727903 on ClinicalTrials.gov |
What this trial studies
This is an observational study that collects laboratory biomarker data at ICU admission and links it with clinical information to build a predictive model of in-hospital mortality for very elderly patients. Participants are adults aged 75 or older admitted from the emergency department to participating ICUs, with consent obtained from the patient or a legal representative and an available informant. Patients transferred from wards, admitted to step-down units, or who die within 24 hours of ICU admission are excluded. The model development will use data from multiple hospitals in the Barcelona area to derive and potentially internally validate risk predictions.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 75 or older who are admitted from the Emergency Department to one of the participating ICUs and can provide consent or have a legal representative and an informant available.
Not a fit: Patients who are younger than 75, transferred from hospital wards, admitted to step-down units, die within the first 24 hours, or who required advanced resuscitation before ED arrival are unlikely to benefit from this model.
Why it matters
Potential benefit: If successful, the model could help clinicians identify high-risk older ICU patients earlier, guiding monitoring, treatment priorities, and timely goals-of-care conversations.
How similar studies have performed: Previous ICU mortality prediction tools (eg, APACHE, SAPS, SOFA) and some biomarker-based models have shown moderate success, but models specifically developed and validated for very elderly ICU populations remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 75 or older. * Admission to an ICU from the Emergency Department. * Availability of or possibility to contact a participant's informant. * Informed consent for participation in the study, either by the participant or a valid legal representative. Exclusion Criteria: Participants meeting any of the following exclusion criteria will not be included in the study: * Patients transferred to the Emergency Department from a hospital ward. * Patients who die within the first 24 hours of ICU admission. * Patients admitted to Step-Down Units. * Patients requiring ICU admission for any of the following reasons: Orotracheal intubation or advanced cardiopulmonary resuscitation performed prior to arrival at the Emergency Department. AV block awaiting pacemaker implantation. Activation of the STEMI or Stroke care pathway. Post-cardiac catheterization for acute coronary syndrome. * Participation in another clinical study involving an intervention, procedure, or visit schedule that is incompatible with the present study.
Where this trial is running
Badalona, Barcelona and 14 other locations
- Hospital German Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)
- Consorci Sanitari Alt Penedès-Garraf — Sant Pere de Ribes, Barcelona, Spain (Not_yet_recruiting)
- Hospital Clinic — Barcelona, Spain (Not_yet_recruiting)
- Hospital de Barcelona — Barcelona, Spain (Not_yet_recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Not_yet_recruiting)
- Hospital de Mataró — Barcelona, Spain (Not_yet_recruiting)
- Hospital de Terrassa — Barcelona, Spain (Not_yet_recruiting)
- Hospital del Mar — Barcelona, Spain (Not_yet_recruiting)
- Hospital Dexeus Barcelona — Barcelona, Spain (Not_yet_recruiting)
- Hospital General de Catalunya — Barcelona, Spain (Not_yet_recruiting)
- Hospital General de Granollers — Barcelona, Spain (Not_yet_recruiting)
- Hospital Sagrat Cor — Barcelona, Spain (Not_yet_recruiting)
- Clinica Girona — Girona, Spain (Not_yet_recruiting)
- Hospital Santa Caterina — Girona, Spain (Not_yet_recruiting)
- Hospital Universitari Dr. Josep Trueta — Girona, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: César Gálvez, Ph.D.
- Email: cgalvez@csapg.cat
- Phone: +34 9389600325
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.