NCT07853911

Brief Summary

Critically ill patients admitted to intensive care units (ICUs) frequently develop elevated blood sugar levels (hyperglycemia) as a result of acute illness-related stress, even if they do not have diabetes. While high blood glucose in the ICU is known to be associated with complications such as acute kidney injury and increased mortality, absolute glucose measurements alone may not distinguish acute stress from pre-existing chronic elevation. The Stress Hyperglycemia Ratio (SHR) evaluates the relative increase in blood glucose by dividing admission plasma glucose by the patient's estimated background average glucose derived from glycated hemoglobin (HbA1c). This measurement reflects the intensity of acute physiologic stress adjusted for baseline glycemic control. The purpose of this prospective observational study is to evaluate the prognostic utility of admission Stress Hyperglycemia Ratio in adult critically ill patients admitted to the intensive care units of Assiut University Hospitals. The study aims to determine whether admission SHR can predict in-hospital ICU mortality, acute kidney injury (AKI), the severity of acute organ failure measured by Sequential Organ Failure Assessment (SOFA) scores, the requirement and duration of invasive mechanical ventilation and vasopressor support, and the overall length of ICU stay. All participants will receive standard clinical care in accordance with institutional ICU protocols; no experimental drugs or clinical interventions will be administered as part of this study.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Keywords

Stress Hyperglycemia RatioSHRIntensive Care UnitSOFA ScoreIn-Hospital MortalityGlycemic ControlMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With In-Hospital ICU Mortality

    All-cause mortality occurring during the index ICU stay. Vital status (alive or deceased) will be recorded from patient medical records upon discharge from the intensive care unit.

    Up to 30 days

Study Arms (2)

High Stress Hyperglycemia Ratio (High SHR) Group

Adult critically ill patients admitted to the ICU whose admission Stress Hyperglycemia Ratio (SHR) - calculated as admission plasma glucose divided by estimated average glucose (eAG = 28.7 \* HbA1c - 46.7) - falls at or above the optimal cutoff determined by receiver operating characteristic (ROC) analysis. Participants receive standard medical care per ICU protocols without experimental intervention.

Low Stress Hyperglycemia Ratio (Low SHR) Group

Adult critically ill patients admitted to the ICU whose admission Stress Hyperglycemia Ratio (SHR) - calculated as admission plasma glucose divided by estimated average glucose (eAG = 28.7 \* HbA1c - 46.7) - falls below the optimal cutoff determined by receiver operating characteristic (ROC) analysis. Participants receive standard medical care per ICU protocols without experimental intervention.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult critically ill patients aged 18 years or older admitted to the Intensive Care Units (ICUs) at Assiut University Hospitals who are expected to require intensive care management, with available admission plasma glucose and early HbA1c measurements.

You may qualify if:

  • Adult patients aged 18 years or older.
  • Admitted to the intensive care unit (ICU) and expected to require ICU care.
  • Availability of admission plasma glucose measurement.
  • Availability of glycated hemoglobin (HbA1c) measurement during the early period of ICU admission to calculate estimated average glucose (eAG) and Stress Hyperglycemia Ratio (SHR).
  • Provision of written informed consent by the patient or their legally authorized representative.

You may not qualify if:

  • Patients younger than 18 years of age.
  • Presence of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) at admission.
  • Conditions known to render HbA1c measurement unreliable (such as recent major blood transfusion or known hemoglobinopathies).
  • Incomplete essential laboratory or clinical data required for the calculation of SHR or study outcome assessment.
  • Patients transferred from another ICU after prolonged critical illness where baseline admission parameters cannot be reliably obtained.
  • Refusal of participation or refusal of consent by the patient or legally authorized representative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical IllnessHyperglycemiaAcute Kidney InjuryMultiple Organ Failure

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09