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 | Not Yet Recruiting DMC

• 1 other identifier: REC-47/08/1796
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

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).

  Within 1 hour of sepsis recognition (Time Zero).

Secondary Outcomes (1)

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

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

Study Arms (2)

Pre-protocol Group (Baseline)

PLACEBO COMPARATOR

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

Protocol Group (Intervention)

EXPERIMENTAL

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

Interventions

Adapted Surviving Sepsis Campaign (SSC) Protocol OTHER

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.

Protocol Group (Intervention)

Standard Clinical Care OTHER

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.

Pre-protocol Group (Baseline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Sepsis; Shock, Septic; Systemic Inflammatory Response Syndrome; Critical Illness

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Model Details: This is a quasi-experimental, pre-post intervention study. It consists of two sequential phases: 1) A retrospective baseline phase (Pre-protocol group) to establish current care standards, followed by 2) A prospective implementation phase (Protocol group) where the adapted Surviving Sepsis Campaign (SSC) bundle is applied to all eligible participants.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03