NCT06729502

Brief Summary

Understanding the frailty levels of critically ill patients using the PFFS at time of admission to ICU. Exploring any associations between frailty, other prognostic factors, and patient outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,350

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress61%
Jan 2025Mar 2027

First Submitted

Initial submission to the registry

December 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 23, 2025

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

December 4, 2024

Last Update Submit

July 22, 2025

Conditions

Frail

Outcome Measures

Primary Outcomes (1)

  • 90-d mortality

    Mortality at 90 days from ICU admission

    up to 90 days from ICU admission

Secondary Outcomes (4)

  • ICU mortality

    During index admission

  • Hospital mortality

    During index admission

  • ICU length of stay

    up to 90 days from ICU admission

  • Hospital length of stay

    Up to 90 days from ICU admission

Interventions

Questionnaire - Pictorial Fit-Frail ScaleOTHER

All patients over 60 years old, or their caregivers, will be asked to fill the PFFS questionnaire

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 60 years old or more who admitted to the ICU for more than 24 hours, for any reason (except from those specified in the exclusion criteria)

You may qualify if:

  • Older adults (age ≥ 60 years) who were admitted to the ICU for more than 24 hours at the participating centers

You may not qualify if:

  • Prior recent admission to an ICU (within 30 days)
  • Admissions for brain death evaluation.
  • Planned admissions to the ICU (i.e for percutaneous tracheostomy, for specific treatment under sedation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Central Study Contacts

Liran Statlender, MD

CONTACT

+97239376590liranst1@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician, principal investigator

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 11, 2024

Study Start

January 26, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

July 23, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)