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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 120
- Primary Endpoint
- Compliance rate with the full 5-item Sepsis One-Hour Bundle.
Study Overview
Brief 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.
Detailed Description
Project Overview Sepsis and septic shock represent a significant global health burden, characterized by life-threatening organ dysfunction resulting from a dysregulated host response to infection. Clinical outcomes are heavily dependent on the speed of recognition and the initiation of evidence-based interventions. This quality improvement (QI) project was designed to address gaps in the timely management of sepsis at the Armed Forces Hospital Jazan (AFHJ) by implementing a standardized clinical protocol in the Emergency Department (ED) and Intensive Care Unit (ICU).
Protocol Framework
The intervention is based on an adaptation of the international Surviving Sepsis Campaign (SSC) guidelines. The protocol integrates two validated scoring systems to enhance diagnostic accuracy and urgency:
National Early Warning Score 2 (NEWS2): Utilized for the initial screening of patients to identify physiological deterioration early.
Sequential Organ Failure Assessment (SOFA): Used to formally assess and track the degree of organ dysfunction.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Due to the nature of quality improvement and protocol implementation in an Emergency Department/ICU setting, healthcare providers and investigators are aware of the intervention being applied.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Pre-protocol Group (Baseline)
his retrospective cohort includes 74 adult patients with suspected sepsis or septic shock treated at AFHJ between January and December 2024. This arm represents the "standard of care" prior to the formal implementation of the adapted sepsis management protocol.
Intervention: Standard Clinical Care (Other)
Protocol Group (Intervention)
his prospective cohort includes 46 adult patients with suspected sepsis or septic shock treated at AFHJ between January and July 2025. These patients were managed according to a structured sepsis protocol involving early screening (NEWS2/SOFA) and the "one-hour bundle."
Intervention: Adapted Surviving Sepsis Campaign (SSC) Protocol (Other)
Outcomes
Primary Outcomes
Compliance rate with the full 5-item Sepsis One-Hour Bundle.
Time Frame: Within 1 hour of sepsis recognition (Time Zero).
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).
Secondary Outcomes
- Length of Stay (LOS) in the Intensive Care Unit (ICU).(From ICU admission to ICU discharge (average 5-7 days).)
Investigators
Tarik Saber Sarhan
Associate Professor Doctor
Al-Azhar University