Predictive Model for Mortality in Older People With Critical Illness (VITA)

December 1, 2025 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

Development of a Predictive Model for Mortality in Patients Aged 75 or Older With Critical Illness

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Del Mar
        • Contact:
        • Principal Investigator:
          • Ana Zapatero
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic
        • Principal Investigator:
          • Pedro Castro
        • Contact:
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital de La Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Carles Subirà
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital General De Catalunya
        • Contact:
        • Principal Investigator:
          • María Dolores Bosque
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital de Barcelona
        • Contact:
        • Principal Investigator:
          • Karla Núñez
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital de Mataró
        • Contact:
        • Principal Investigator:
          • Estel Güell
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital de Terrassa
        • Contact:
        • Principal Investigator:
          • Manuel Buitrago
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Dexeus Barcelona
        • Contact:
        • Principal Investigator:
          • Elida Amestoy
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital General de Granollers
        • Contact:
        • Principal Investigator:
          • Zaira Chova
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Sagrat Cor
        • Contact:
        • Principal Investigator:
          • Omar Correa
      • Girona, Spain
        • Not yet recruiting
        • Hospital Universitari Dr. Josep Trueta
        • Contact:
        • Principal Investigator:
          • Jordi Parisi
      • Girona, Spain
        • Not yet recruiting
        • Hospital Santa Caterina
        • Contact:
        • Principal Investigator:
          • Malena Tejada
      • Girona, Spain
        • Not yet recruiting
        • Clinica Girona
        • Contact:
        • Principal Investigator:
          • Mariano Rinaudo
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital German Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Regina Roig, MD
      • Sant Pere de Ribes, Barcelona, Spain, 08810
        • Not yet recruiting
        • Consorci Sanitari Alt Penedès-Garraf
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Gerber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to a Intensive Care Unit

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: Day 90
mortality on day 90 from admission to Intensive Care Unit
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSAPG-66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

After publication of main results of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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