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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glucose Fluctuations in Sepsis

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.

• Study Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

• Study Contact: Name: Shaban N S Tamer, Bachelor degree of medicin; Phone Number: +201286606934; Email: shabaan2021@icloud.com
• Study Contact Backup: Name: Dina A Ahmed, Doctorate of internal medicine; Phone Number: +20106 3040703; Email: dinaalihamad@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critical care unit of assiut university hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	ICU mortality due to septic shock and associated glucose level fluctuations pre and post antibiotic administration	Baseline
AKI	number of patients suffering from AKI due to septic shock	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for vasopressor support within first 24 hours.	Number of patients who needed norepinephrine or other vasopressors during first day of ICU admission	First 24 hours of ICU admission
Length of ICU stay	Length of ICU stay until improvement or death	Start from patient admission to ICU unti patient discharge or death for any cause (whichever comes first) up to 1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Muhammad Abbas Al masry, Doctorate of internal medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Glucose fluctuations in sepsis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Patients may not agree

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No