NCT06888206

Brief Summary

Rationale: Age is often considered a strong factor that determines the outcomes in critically ill patients. In a resource limited low middle income country (LMIC) like Nepal, the age factor is often considered when making treatment decisions by family especially when considering limiting treatment modalities. Whether or not this consideration of age for outcome prediction is appropriate however is a different discussion especially considering the fact that actual data from Nepalese ICUs are missing. Study Objective: To find the impact of age on mortality in critically ill patients. Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who are admitted to the ICU. Duration: Retrospective data from the 5-year period between November, 2019 to December, 2024. Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH). Interventions: Not applicable Expected results: The study will help determine the mortality of the critically ill adult patients in terms of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,189

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

5.2 years

First QC Date

March 15, 2025

Last Update Submit

March 20, 2025

Conditions

Keywords

AgeMortalityIntensive care unitLow-middle income country

Outcome Measures

Primary Outcomes (1)

  • All cause ICU mortality

    * To determine the all cause ICU mortality among rates among patients in ICU grouped according to Medical Subject Heading(MeSH) * Young adult: 19-24 years * Adult: 25-44 years * Middle aged: 45-64 years * Older adult (Senior): \>65 years * To determine the all cause ICU mortality among rates among patients in ICU grouped into decades * To determine the all cause ICU mortality among rates among patients \>65 years in ICU according to WHO classification of elderly * Young-old: 60-74 years * Old-old: 75- 84 years * Oldest-Old: \>85 years

    2019, November to 2024 December

Study Arms (4)

Young adult

Patients admitted to the ICU in the age group less than 24

Adult

Adults of the age group 25-44

Middle age

Patients of the age group 45-64

Older adult

Patients of the age group \>65 years

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the ICUs of Tribhuvan University Teaching Hospital will be enrolled for this registry based retrospective study

You may qualify if:

  • Age\>18 years Admission to the ICU

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital

Mahārājgañj, Bagmati, 44600, Nepal

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 15, 2025

First Posted

March 21, 2025

Study Start

November 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

The de-identified patient data may be shared with the statistician for statistical analysis

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
March 2025- December 2025
Access Criteria
All the de-identified patient data from the registry will be available to data handlers who will enter it in a format suitable for statistical analysis which will be available for the statistician for analysis.

Locations