Usage of Glucose Fluctuations as a Prognostic Marker in Septic Shock Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Glucose Fluctuations in Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pre-Antibiotic Glucose Fluctuations and Glycemic Shock Index as a Predictor of Sepsis Severity and Clinical Outcomes in ICU Patient
Overview
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.
Primary outcome measures
- ICU mortality [Time frame: Baseline]
- AKI [Time frame: Baseline]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Steroid use in prior 48 hours.
- DKA, HHS, or acute pancreatitis.
- Incomplete glucose data or delayed documentation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07234526 · Glucose fluctuations in sepsis