NCT06082154

Brief Summary

Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. The outcome of mortality reflects the caliber of ICU treatment. This is a prospective observational study that will include all patients diagnosed with sepsis for point-of-care ultrasonography within 24 hours of admission to the ICU from April 26, 2023, to March 30, 2024, and create a model that will predict 28 day outcome in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 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

April 26, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

October 7, 2023

Last Update Submit

August 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 28 day status alive or dead

    patient will be followed for 28 days from day of icu admission to find out their status being alive or dead

    28 days

Interventions

Patient will undergo multiorgan ultrasonography

Eligibility Criteria

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

Patient who are diagnosed as having sepsis as per Sepsis 3 definition

You may qualify if:

  • Age \>=16 yrs within 24 hour of ICU admission diagnosed as Sepsis as per Sepsis 3

You may not qualify if:

  • USG cannot be done within 24 hour of admission to icu If USG cannot be done for 2 parameters Who do not give consent Withdrawal of active life support Do not intubate(DNI) or do not resuscitate(DNR) order at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashmita Paudel

Kathmandu, Bagmati, 1524, Nepal

Location

MeSH Terms

Conditions

Sepsis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 13, 2023

Study Start

April 26, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

August 2, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations