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临床试验/NCT07234526
NCT07234526尚未招募不适用

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

Assiut University0 个研究点目标入组 105 人开始时间: 2026年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
105
主要终点
ICU mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Steroid use in prior 48 hours.
  • DKA, HHS, or acute pancreatitis.
  • Incomplete glucose data or delayed documentation.

结局指标

主要结局

ICU mortality

时间窗: Baseline

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

AKI

时间窗: Baseline

number of patients suffering from AKI due to septic shock

次要结局

  • Need for vasopressor support within first 24 hours.(First 24 hours 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaban Nady Sedky Tamer

Resident physician

Assiut University

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