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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 years or older.

Clinical suspicion of sepsis or a confirmed diagnosis of sepsis upon admission to the Emergency Department (ED) or Intensive Care Unit (ICU).

Presence of symptoms meeting the criteria for the sepsis management protocol during the study period.

Disqualifiers

Patients transferred from other healthcare facilities after sepsis treatment had already been initiated.

End-of-life cases or patients with "Do Not Attempt Resuscitation" (DNAR) status where data sets are incomplete.

Cases with insufficient medical documentation that prevents accurate outcome measurement or bundle compliance tracking.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Adapted Surviving Sepsis Campaign (SSC) Protocol

    Other intervention

    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.

  • Standard Clinical Care

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Pre-protocol Group (Baseline)Placebo comparator 1 intervention
Group B: Protocol Group (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Compliance rate with the full 5-item Sepsis One-Hour Bundle.

The percentage of patients who received all five components of the adapted Surviving Sepsis Campaign (SSC) bundle within 60 minutes of "Time Zero" (triage or recognition). The five components are: 1. Lactate measurement, 2. Blood cultures, 3. Broad-spectrum antibiotics, 4. 30 mL/kg crystalloid fluid, and 5. Vasopressors (if indicated).

Time frame
Within 1 hour of sepsis recognition (Time Zero).

Secondary outcomes

1

Length of Stay (LOS) in the Intensive Care Unit (ICU).

The duration of stay in the ICU measured in days. This measure evaluates if the timely implementation of the sepsis bundle leads to faster clinical stabilization and earlier discharge from critical care.

Time frame
From ICU admission to ICU discharge (average 5-7 days).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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