NCT07460024

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2026-03-10
• Last updated: 2026-03-10