Usage of Glucose Fluctuations as a Prognostic Marker in Septic Shock Patients
- Conditions
- Glucose Fluctuations in Sepsis
- Registration Number
- NCT07234526
- Lead Sponsor
- Assiut University
- Brief 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.
* 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 105
- 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.
- Steroid use in prior 48 hours.
- DKA, HHS, or acute pancreatitis.
- Incomplete glucose data or delayed documentation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICU mortality Baseline ICU mortality due to septic shock and associated glucose level fluctuations pre and post antibiotic administration
AKI Baseline number of patients suffering from AKI due to septic shock
- Secondary Outcome Measures
Name Time Method Need for vasopressor support within first 24 hours. First 24 hours of ICU admission Number of patients who needed norepinephrine or other vasopressors during first day of ICU admission
Length of ICU stay Start from patient admission to ICU unti patient discharge or death for any cause (whichever comes first) up to 1 year Length of ICU stay until improvement or death