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- Klinische proef NCT07853911
Prognostic Value of Stress Hyperglycemia Ratio in Critically Ill Patients
Prognostic Value of Stress Hyperglycemia Ratio for In-Hospital Mortality and Acute Organ Dysfunction in Critically Ill Patients
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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants With In-Hospital ICU Mortality
Tijdsspanne: Up to 30 days
|
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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Pathologische processen
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Ziekte attributen
- Metabole ziekten
- Glucosemetabolismestoornissen
- Nierinsufficiëntie
- Schok
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Kritieke ziekte
- Acuut nierletsel
- Hyperglykemie
- Meervoudig orgaanfalen
Andere studie-ID-nummers
- Prognostic Value of SHR in ICU
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .