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Life sciences · Interventional Study
ClinicalTrials.gov · October 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07460024). This is a study registration, not published results. Lead sponsor: Al-Azhar University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ACTUAL). Conditions: Sepsis, Septic Shock, Systemic Inflammatory Response Syndrome (SIRS), Critical Illness. Interventions: OTHER: Adapted Surviving Sepsis Campaign (SSC) Protocol; OTHER: Standard Clinical Care. Primary outcome measures: Compliance rate with the full 5-item Sepsis One-Hour Bundle. , Within 1 hour of sepsis recognition (Time Zero).. 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.