Is a Positive NECPAL in ICU Patients Associated With High... | NCT07007156

Studies
Is a Positive NECPAL in ICU Patients Associated With Higher Mortality

NCT07007156

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Status

Recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

199Estimated

Phase

Not provided

Conditions

Acute Disease

Interventions

NECPAL positive

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

Jun 12, 2025Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

May 28, 2025

First Submission Date that Met QC Criteria

Jun 4, 2025

First Posted Date

Jun 5, 2025Actual

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 5, 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

Description Module

Brief Summary

The aim of the present study is to evaluate the usefulness of the NECPAL scale in identifying Intensive Care Unit (ICU)-admitted patients at higher risk of dying within 90 days of ICU admission

Detailed Description

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

199Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NECPAL positive	Other	This group has a positive result for NECPAL scale

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Patients who dye at 90-day from ICU admission	From baseline to 90-day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who meet all of the following inclusion criteria may be included in the study:
Men and women aged 75 years or older.
Admission to the ICU of the study center.
Legal capacity to provide informed consent.
Signed informed consent for study inclusion, either by the participant or their legal representative.

Exclusion Criteria:

Participants who meet any of the following exclusion criteria may not be included in the study:

-Death within the first 24 hours of ICU admission.

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 aged 75 years or older who are admitted to an ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diana Gutiérrez, MD	Contact	+34938960025		dpgutierrez@csapg.cat
Noemí Casaponsa	Contact	+34 938960025	43197	recerca@csapg.cat

Overall Officials

Name	Affiliation	Role
Diana Gutiérrez, MD	CSAPG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CSAPG	Recruiting	Sant Pere de Ribes	Barcelona	08800	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000208	Acute Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided