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

NCT ID: NCT07234526

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-12-01
• Study Completion Date: 2029-06-01

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.

Conditions

Glucose Fluctuations in Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shaban Nady Sedky Tamer

Resident physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Abbas Al masry, Doctorate of internal medicine

Role: STUDY_DIRECTOR

Central Contacts

Shaban N S Tamer, Bachelor degree of medicin

Role: CONTACT

shabaan2021@icloud.com

+201286606934

Dina A Ahmed, Doctorate of internal medicine

Role: CONTACT

dinaalihamad@aun.edu.eg

+20106 3040703

Other Identifiers

Glucose fluctuations in sepsis

Identifier Type: -

Identifier Source: org_study_id