Predictive Model for Mortality in Older People With Criti... | NCT06727903

Studies
Predictive Model for Mortality in Older People With Critical Illness

NCT06727903

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Status

Recruiting

Last Update Posted

Dec 2, 2025Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Critical Illness

Interventions

laboratory biomarker analysis

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 5, 2024

First Submission Date that Met QC Criteria

Dec 10, 2024

First Posted Date

Dec 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2025

Last Update Posted Date

Dec 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other	Results of laboratory biomarker analysis will be analyzed as predictors for mortality

Measure	Description	Time Frame
mortality	mortality on day 90 from admission to Intensive Care Unit	Day 90

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients admitted to a Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
César Gálvez, Ph.D.	Contact	+34 9389600325		cgalvez@csapg.cat
Noemí Casaponsa	Contact	+34 938960025	43197	recerca@csapg.cat

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital German Trias i Pujol	Recruiting	Badalona	Barcelona	08916	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

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).

Types

Study Protocol
Informed Consent Form (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.

URL

Not provided

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms