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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07234526
Enrollment
105
Registered
2025-11-18
Start date
2026-12-01
Completion date
2029-06-01
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Fluctuations in Sepsis

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ICU mortalityBaselineICU mortality due to septic shock and associated glucose level fluctuations pre and post antibiotic administration
AKIBaselinenumber of patients suffering from AKI due to septic shock

Secondary

MeasureTime frameDescription
Need for vasopressor support within first 24 hours.First 24 hours of ICU admissionNumber of patients who needed norepinephrine or other vasopressors during first day of ICU admission
Length of ICU stayStart from patient admission to ICU unti patient discharge or death for any cause (whichever comes first) up to 1 yearLength of ICU stay until improvement or death

Contacts

Primary ContactShaban N S Tamer, Bachelor degree of medicin
shabaan2021@icloud.com+201286606934
Backup ContactDina A Ahmed, Doctorate of internal medicine
dinaalihamad@aun.edu.eg+20106 3040703

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026