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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Critical Illness; Septic Shock; Systemic Inflammatory Response Syndrome (SIRS)
• Intervention / Treatment: Other: Standard Clinical Care; Other: Adapted Surviving Sepsis Campaign (SSC) Protocol

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.

The One-Hour Bundle Intervention

The core of the clinical intervention is the "One-Hour Bundle," which mandates that five key actions be initiated within 60 minutes of sepsis recognition:

Lactate Measurement: To identify tissue hypoperfusion (repeated if initial lactate is >2 mmol/L).

Microbiological Diagnostics: Obtaining blood cultures prior to the administration of antimicrobial agents to ensure targeted therapy later.

Empiric Antimicrobials: Rapid administration of broad-spectrum antibiotics to combat the underlying infection.

Fluid Resuscitation: Immediate infusion of 30 mL/kg of crystalloid for patients presenting with hypotension or high lactate levels.

Vasopressor Support: Application of vasopressors (typically norepinephrine) if the patient remains hypotensive during or after fluid resuscitation to maintain a Mean Arterial Pressure (MAP) of ≥65 mm Hg.

Implementation Strategy

The project utilized a multi-disciplinary approach involving consultants from Anesthesiology, ICU, and Surgery, alongside nursing leadership and medication safety officers. Implementation was supported by:

Educational Workshops: Training frontline staff on NEWS2 and SOFA scoring.

Visual Aids: Strategic placement of the sepsis algorithm in high-acuity areas.

Quality Oversight: Continuous monitoring of compliance through data collection sheets to identify and remove systemic barriers to rapid care.

Study Methodology The project followed a quasi-experimental pre-post intervention design. The Pre-protocol phase involved a retrospective review of cases to establish a baseline of care compliance and patient outcomes. The Protocol phase involved the prospective enrollment of patients following the formal introduction of the new guidelines. By standardizing the "time to antibiotics" and "time to fluid bolus," the study aimed to demonstrate that protocolized care directly correlates with reduced Intensive Care Unit (ICU) and hospital Length of Stay (LOS), as well as a significant reduction in sepsis-related mortality rates.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.
Experimental: 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."	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within 1 hour of sepsis recognition (Time Zero).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From ICU admission to ICU discharge (average 5-7 days).

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Critical Illness; Sepsis; Shock, Septic; Systemic Inflammatory Response Syndrome; Health Care Quality, Access, and Evaluation; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Epidemiologic Study Characteristics; Clinical Protocols
• Other Study ID Numbers: REC-47/08/1796

Drug and device information, study documents

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