SepsisNCT07460024
Implementation of Timely Management of Sepsis and Septic Shock Protocol in the Emergency Department and Intensive Care Unit: A Quality Improvement Project at AFHJ
A study testing Adapted Surviving Sepsis Campaign (SSC) Protocol and Standard Clinical Care in people with Sepsis and Septic Shock, run by Al-Azhar University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Systemic Inflammatory Response Syndrome (SIRS)
- What is being tested?
- Adapted Surviving Sepsis Campaign (SSC) Protocol and Standard Clinical Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Mar 2026to 3 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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.
- Being tested
- Adapted Surviving Sepsis Campaign (SSC) Protocol, Standard Clinical Care
- Medical subject headings
- Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Surviving Sepsis Campaign (SSC) ProtocolOther
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.
Standard Clinical CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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." Receives: Other: Adapted Surviving Sepsis Campaign (SSC) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 1 hour of sepsis recognition (Time Zero).
Secondary outcomes (1)
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.
Measured: From ICU admission to ICU discharge (average 5-7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start3 Mar 2026
- Primary completion30 Aug 2026
- Study completion3 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Saber Sarhan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460024
- Sponsor's protocol ID
- REC-47/08/1796
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Timely Management of Sepsis and Septic Shock Protocol in the Emergency Department and Intensive Care Unit: A Quality Improvement Project at AFHJ
- ClinicalTrials.gov ID
- NCT07460024
- Acronym / sponsor ID
- REC-47/08/1796
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 3 Oct 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-protocol Group (Baseline) | Placebo comparator | Other: Standard Clinical Carehis 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. |
| Protocol Group (Intervention) | Experimental | Other: Adapted Surviving Sepsis Campaign (SSC) Protocolhis 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." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Surviving Sepsis Campaign (SSC) ProtocolA 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 | Protocol Group (Intervention) |
| Standard Clinical CareTraditional 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. | Other | Pre-protocol Group (Baseline) |
Primary outcome
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).
1 secondary outcome
Length of Stay (LOS) in the Intensive Care Unit (ICU).
Time frame: From ICU admission to ICU discharge (average 5-7 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Surviving Sepsis Campaign (SSC) Protocol and Standard Clinical Care in people with Sepsis and Septic Shock, run by Al-Azhar University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate with the full 5-item Sepsis One-Hour Bundle. (time frame: Within 1 hour of sepsis recognition (Time Zero).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.