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NCT Number: NCT07234526

Usage of Glucose Fluctuations as a Prognostic Marker in Septic Shock Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ICU mortality

    Time frame: Baseline

    ICU mortality due to septic shock and associated glucose level fluctuations pre and post antibiotic administration

  2. AKI

    Time frame: Baseline

    number of patients suffering from AKI due to septic shock

Secondary outcomes

  1. Need for vasopressor support within first 24 hours.

    Time frame: First 24 hours of ICU admission

    Number of patients who needed norepinephrine or other vasopressors during first day of ICU admission

  2. 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

    Length of ICU stay until improvement or death

Study contacts

Contact information is provided by the study sponsor or research team.

Dina A Ahmed, Doctorate of internal medicine

CONTACT

[email protected]

+20106 3040703

Shaban N S Tamer, Bachelor degree of medicin

CONTACT

[email protected]

+201286606934

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Pre-Antibiotic Glucose Fluctuations and Glycemic Shock Index as a Predictor of Sepsis Severity and Clinical Outcomes in ICU Patient

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Nov 18, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.