NCT06727903

Brief Summary

The present study aims to develop a predictive model to identify elderly patients with the highest likelihood of mortality upon admission to an intensive care unit.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

December 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

December 5, 2024

Last Update Submit

December 1, 2025

Conditions

Keywords

Critical IllnessMortalityAgedIntensive Care Units

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality on day 90 from admission to Intensive Care Unit

    Day 90

Interventions

Results of laboratory biomarker analysis will be analyzed as predictors for mortality

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to a Intensive Care Unit

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital German Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Consorci Sanitari Alt Penedès-Garraf

Sant Pere de Ribes, Barcelona, 08810, 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

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

César Gálvez, Ph.D.

CONTACT

Noemí Casaponsa

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 11, 2024

Study Start

March 20, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After publication of main results of the study.
Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations