NCT06163976

Brief Summary

Prospective observational study recruiting elderly patients of 60 years and above admitted to Intensive Care Unit (ICU), to study multiple domains of biomarkers ability to predict mortality of patients during intensive care unit admission and functional disability in survivors after ICU discharge

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
329

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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 Start

First participant enrolled

July 13, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

August 26, 2023

Last Update Submit

December 1, 2023

Conditions

Keywords

mortality predictionfunctional disability after icuolder adultsicu

Outcome Measures

Primary Outcomes (1)

  • Development and validation of a predictive mathematical model to predict the outcome of mortality during ICU stay

    Outcome of mortality at ICU discharge, up to 30-days.

    From admission to intensive care unit until discharge from ICU, up to 30-days, whichever came first.

Secondary Outcomes (1)

  • Development of predictive modelling to predict severe functional disability in ICU survivors

    Measured at 1 year after ICU discharged among those patients discharged alive from the hospital

Study Arms (2)

ICU Survivor

Elderly patients admitted to intensive care unit and discharged alive

ICU Mortality

Elderly patients admitted to intensive care unit and died during ICU stay

Eligibility Criteria

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

Elderly patients, 60 years and above who admitted to intensive care unit

You may qualify if:

  • years old and above at the time of ICU admission

You may not qualify if:

  • Second or subsequent ICU admission in the same Hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Hospital Queen Elizabeth II

Kota Kinabalu, Sabah, 88300, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88300, Malaysia

RECRUITING

Sultan Ahmad Shah Medical Centre @IIUM

Kota Kinabalu, Sabah, 88300, Malaysia

RECRUITING

Study Officials

  • Abdul Jabbar Ismail

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Jabbar Ismail, MBBS

CONTACT

Wan Fadzlina Wan Shukeri, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2023

First Posted

December 11, 2023

Study Start

July 13, 2022

Primary Completion

July 13, 2024

Study Completion

December 31, 2024

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations