Glucose Fluctuations in SepsisNCT07234526
Usage of Glucose Fluctuations as a Prognostic Marker in Septic Shock Patients
An observational study of Glucose Fluctuations in Sepsis, run by Assiut University.
Trial summary
To determine whether glucose fluctuations prior to antibiotic administration are associated with sepsis severity and poor clinical outcomes. To assess if the time to Glycemic Normalization after Antibiotic Initiation can be used as an Early Prognostic Indicator in Sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Fluctuations in Sepsis
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Critical care unit of assiut university hospital.
Who may be able to join
- Adults ≥18 years admitted to ICU with suspected or confirmed sepsis.
- Sepsis diagnosed using Sepsis-3 criteria (infection + SOFA ≥2).
- At least 2 blood glucose readings within 6 hours prior to the first dose of antibiotics.
- at least 3 after starting antibiotics within 24 hours.
Who cannot join
- Steroid use in prior 48 hours.
- DKA, HHS, or acute pancreatitis.
- Incomplete glucose data or delayed documentation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pre-Antibiotic Glucose Fluctuations and Glycemic Shock Index as a Predictor of Sepsis Severity and Clinical Outcomes in ICU Patient
To determine whether glucose fluctuations prior to antibiotic administration are associated with sepsis severity and poor clinical outcomes.
- To assess if the time to Glycemic Normalization after Antibiotic Initiation can be used as an Early Prognostic Indicator in Sepsis.
- To evaluate the Glycemic Shock Index (GSI) as a Combined Marker of Hemodynamic and Metabolic Stress in ICU Sepsis Patients.
Read the detailed description
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection. It is a major cause of death in intensive care units (ICUs) despite advances in treatment. One of the body's common responses to sepsis is a disturbance in blood sugar levels, even in patients without diabetes. These changes, known as glycemic variability, include both high and low glucose levels and rapid swings between them.
Recent studies suggest that glycemic variability the early hours of sepsis may be linked to worse outcomes, including organ failure and death .Unlike average glucose levels, these fluctuations can reflect how stressed the body is.
A newer marker called the Glycemic Shock Index (GSI) - calculated by dividing blood glucose by mean arterial pressure (MAP)- may help capture both metabolic and circulatory stress.
Another factor of interest is the time it takes for blood sugar to return to normal after starting antibiotics.
Early normalization may signal a better response to treatment, while persistent abnormal levels could predict complications.
Understanding how early glucose changes relate to sepsis severity may help us identify high-risk patients sooner. This study focuses on glucose fluctuations before antibiotics, time to glucose normalization, and GSI, and how they relate to outcomes like mortality, organ failure like AKI and ICU stay.
- Conditions
- Glucose Fluctuations in Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
ICU mortality due to septic shock and associated glucose level fluctuations pre and post antibiotic administration
Measured: Baseline
AKI
number of patients suffering from AKI due to septic shock
Measured: Baseline
Secondary outcomes (2)
Need for vasopressor support within first 24 hours.
Number of patients who needed norepinephrine or other vasopressors during first day of ICU admission
Measured: First 24 hours of ICU admission
Length of ICU stay
Length of ICU stay until improvement or death
Measured: Start from patient admission to ICU unti patient discharge or death for any cause (whichever comes first) up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Fluctuations in SepsisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaban Nady Sedky Tamer, Assiut University
- Investigators
- Muhammad Abbas Al masry, Doctorate of internal medicine, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234526
- Sponsor's protocol ID
- Glucose fluctuations in sepsis
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patients may not agree
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Antibiotic Glucose Fluctuations and Glycemic Shock Index as a Predictor of Sepsis Severity and Clinical Outcomes in ICU Patient
- ClinicalTrials.gov ID
- NCT07234526
- Acronym / sponsor ID
- Glucose fluctuations in sepsis
- Conditions
- Glucose Fluctuations in Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 18 Nov 2025 (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.
To determine whether glucose fluctuations prior to antibiotic administration are associated with sepsis severity and poor clinical outcomes.
- To assess if the time to Glycemic Normalization after Antibiotic Initiation can be used as an Early Prognostic Indicator in Sepsis.
- To evaluate the Glycemic Shock Index (GSI) as a Combined Marker of Hemodynamic and Metabolic Stress in ICU Sepsis Patients.
Detailed description
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection. It is a major cause of death in intensive care units (ICUs) despite advances in treatment. One of the body's common responses to sepsis is a disturbance in blood sugar levels, even in patients without diabetes. These changes, known as glycemic variability, include both high and low glucose levels and rapid swings between them.
Recent studies suggest that glycemic variability the early hours of sepsis may be linked to worse outcomes, including organ failure and death .Unlike average glucose levels, these fluctuations can reflect how stressed the body is.
A newer marker called the Glycemic Shock Index (GSI) - calculated by dividing blood glucose by mean arterial pressure (MAP)- may help capture both metabolic and circulatory stress.
Another factor of interest is the time it takes for blood sugar to return to normal after starting antibiotics.
Early normalization may signal a better response to treatment, while persistent abnormal levels could predict complications.
Understanding how early glucose changes relate to sepsis severity may help us identify high-risk patients sooner. This study focuses on glucose fluctuations before antibiotics, time to glucose normalization, and GSI, and how they relate to outcomes like mortality, organ failure like AKI and ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical care unit of assiut university hospital.
Key inclusion criteria (4 listed)
- Adults ≥18 years admitted to ICU with suspected or confirmed sepsis.
- Sepsis diagnosed using Sepsis-3 criteria (infection + SOFA ≥2).
- At least 2 blood glucose readings within 6 hours prior to the first dose of antibiotics.
- at least 3 after starting antibiotics within 24 hours.
Key exclusion criteria (3 listed)
- Steroid use in prior 48 hours.
- DKA, HHS, or acute pancreatitis.
- Incomplete glucose data or delayed documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU mortality
Time frame: Baseline
ICU mortality due to septic shock and associated glucose level fluctuations pre and post antibiotic administration
AKI
Time frame: Baseline
number of patients suffering from AKI due to septic shock
2 secondary outcomes
Need for vasopressor support within first 24 hours.
Time frame: First 24 hours of ICU admission
Length of ICU stay
Time frame: Start from patient admission to ICU unti patient discharge or death for any cause (whichever comes first) up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided. Patients may not agree
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.
Muhammad Abbas Al masry, Doctorate of internal medicine study director
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Fluctuations in Sepsis, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaban N S Tamer, Bachelor degree of medicin (+201286606934, shabaan2021@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: Baseline). The study lists 2 primary outcomes in all. 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 19 Nov 2025.