A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Device: ultrasound

• Study Type: Observational
• Enrollment (Estimated): 186

Contacts and Locations

• Study Contact: Name: Ashmita Paudel, MD; Phone Number: 9845362257; Email: paudel.ashmita2000@gmail.com
• Study Contact Backup: Name: Dr Pramesh Sunder Shrestha, DM critical care medicine; Phone Number: 9841298710

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 1524
      • Recruiting
      • Ashmita Paudel
      • Contact: Ashmita Paudel, MD; Phone Number: 977 9845362257; Email: paudel.ashmita2000@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 506(6-11)E2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No