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Implementation of Timely Management of Sepsis and Septic Shock Protocol in the Emergency Department and Intensive Care Unit: A Quality Improvement Project at AFHJ

NCT07460024 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-10

No results posted yet for this study

Summary

Study Title: Implementation of a Sepsis Management Protocol at Armed Forces Hospital Jazan (AFHJ).

Purpose: The purpose of this quality improvement project is to determine if implementing a standardized, evidence-based "sepsis bundle" can improve the care and survival of patients with sepsis and septic shock in the Emergency Department (ED) and Intensive Care Unit (ICU).

What the Study Involves:

Researchers will implement a specific set of clinical guidelines based on the international Surviving Sepsis Campaign. This include:

Using a scoring system (NEWS2 and SOFA) to identify sick patients earlier.

Ensuring patients receive five critical treatments (the "one-hour bundle") within 60 minutes of diagnosis, including blood tests, IV fluids, and antibiotics.

Comparison:

The study will compare the outcomes of 74 patients treated before the protocol was introduced (the "Pre-protocol group") to 46 patients treated after the new protocol was put into effect (the "Protocol group").

Expected Outcome:

The goal is to increase the number of patients who receive all necessary treatments within one hour from less than 15% to at least 60%. The study also aims to see if this protocol leads to shorter hospital stays and lower mortality rates.

Conditions

  • Sepsis
  • Septic Shock
  • Systemic Inflammatory Response Syndrome (SIRS)
  • Critical Illness

Interventions

OTHER

Adapted Surviving Sepsis Campaign (SSC) Protocol

A multi-component clinical management strategy focusing on early recognition and rapid treatment. Key elements include: Screening: Use of National Early Warning Score 2 (NEWS2) at triage. Diagnosis: Use of Sequential Organ Failure Assessment (SOFA) to identify organ dysfunction. The One-Hour Bundle: Execution of five tasks within 60 minutes: (1) Measuring lactate, (2) Obtaining blood cultures, (3) Administering broad-spectrum antibiotics, (4) IV fluid resuscitation (30 mL/kg) for hypotension or high lactate, and (5) Vasopressors to maintain MAP ≥ 65 mmHg.

OTHER

Standard Clinical Care

Traditional sepsis management as practiced at the institution prior to the implementation of the standardized QI protocol. This care was characterized by inconsistent bundle compliance and variable timing of antibiotic administration and fluid resuscitation.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-10-31
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07460024 on ClinicalTrials.gov