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

A

Assiut University

Status

Begins enrollment in 9 months

Conditions

Glucose Fluctuations in Sepsis

Study type

Observational

Funder types

Other

Identifiers

NCT07234526
Glucose fluctuations in sepsis

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Central trial contact

Dina A Ahmed, Doctorate of internal medicine; Shaban N S Tamer, Bachelor degree of medicin

Data sourced from clinicaltrials.gov

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