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Clinical Trials/CTRI/2025/07/090571
CTRI/2025/07/090571
Recruiting
Not Applicable

A prospective observational Study evaluating the impact of combining the One-Hour Sepsis Bundle and Point-of-Care Ultrasound (POCUS) in Sepsis and Septic Shock Patients presenting to Emergency Department in a Tertiary Care Hospital, in Manipur

MUHAMMED SHADIL K E1 site in 1 country110 target enrollmentStarted: July 16, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
MUHAMMED SHADIL K E
Enrollment
110
Locations
1
Primary Endpoint
To evaluate the impact of combining the 1-hour sepsis bundle with POCUS on clinical outcomes (change in qSOFA, NEWS2, Lactate and Blood Pressure (MAP) ) in patients with sepsis or septic shock presenting to the Emergency Department.

Overview

Brief Summary

Sepsis and septic shock remain leading causes of morbidity and mortality worldwide. Early identification and prompt treatment are critical to improving outcomes.This thesis aims to evaluate the impact of combining the 1-hour sepsis bundle with POCUS in the management of sepsis and septic shock patients presenting to Emergency Department in a tertiary care hospital, assessing its effects on patient outcomes, time to intervention, and clinical decision-making The study will involve Patients presenting to the ED with suspected sepsis or septic shock based on clinical criteria (e.g. qSOFA,NEWS2 score).It is anticipated that the use of POCUS in conjunction with the 1-hour sepsis bundle will result in Quicker identification and treatment of sepsis, Improved fluid resuscitation and cardiac optimization, More efficient management of septic shock.Data will be analyzed using appropriate statistical methods, adjusting for confounders and handling missing data with multiple imputation. This study aims to evaluate the impact of combining the 1-hour sepsis bundle with POCUS in the management of sepsis and septic shock patients presenting to Emergency Department and results of the study may ultimately contribute to evidence-based guidelines in the field of Emergency Medicine.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients presenting to the ED with suspected sepsis or septic shock based on clinical criteria (e.g. qSOFA,NEWS2 score).

Exclusion Criteria

  • Patients (close relatives in case of unconscious patients) who refuse to give consent;Patients with age less than18 years and more than 65 years;Pregnant women;Known terminal illness with a prognosis of less than 6 months;Contraindications to ultrasound (e.g., extensive body surface area edema);Patients with spinal cord injury.

Outcomes

Primary Outcomes

To evaluate the impact of combining the 1-hour sepsis bundle with POCUS on clinical outcomes (change in qSOFA, NEWS2, Lactate and Blood Pressure (MAP) ) in patients with sepsis or septic shock presenting to the Emergency Department.

Time Frame: Period of one and half | years from june 2025 to December 2026.

Secondary Outcomes

  • 1) To assess the time to intervention (antibiotics, fluids, vasopressors) in sepsis and septic shock patients.(2) To evaluate the accuracy and utility of POCUS in assessing volume status, cardiac function, and identifying potential sources of infection in septic patients.)

Investigators

Sponsor
MUHAMMED SHADIL K E
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

MUHAMMED SHADIL K E

Shija Hospitals and Research Institute

Study Sites (1)

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