NCT03511742

Brief Summary

Aim of the study is to describe the functional characteristics of Icus in Uganda and their @8-day patient characteristics it is a prospective cohort study .All Icus in Uganda will be included and their admitted patients followed upto 28 days in the ICU for mortality

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
367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

April 10, 2018

Last Update Submit

April 26, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 28 day mortality

    Total number of patients who died during the study period within 28 days over the total number recruited, and a survival analysis will be plowed on a Kaplan Meier

    3 months

  • functional characteristics of ICUs in Uganda

    outcome measure will be descriptive, that is interms of ICU location(urban or rural), staffing (nurse to patient ratio), infrastructure(floor space cm2), monitoring equipment, services rendered(organ support), and the ICU operation models(closed versus open) will be assessed for association with patient outcome

    3 months

Secondary Outcomes (1)

  • factors associated with mortality

    3 months

Eligibility Criteria

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

Target population Critically ill patients in all Intensive care units in Uganda Accessible population. All ICUs in Uganda. All patients admitted to the intensive care units in Uganda during the study period.

You may qualify if:

  • All new patients admitted to Uganda's Intensive Care Units ICUs in Uganda whose unit heads verbally consent to participate in the study.

You may not qualify if:

  • Patients transferred in from another unit will not be re recruited. ICUs that don't consent to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atumanya Patience

Kampala, 256, Uganda

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Anesthesia and critical care

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 30, 2018

Study Start

January 8, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 30, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

analyses data will be published in a peer reviewed journal

Shared Documents
SAP, CSR, ANALYTIC CODE
Time Frame
within 6 months
Access Criteria
open access

Locations