- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With In-Hospital ICU Mortality
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Sykdomsattributter
- Metabolske sykdommer
- Glukosemetabolismeforstyrrelser
- Nyreinsuffisiens
- Sjokk
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Kritisk sykdom
- Akutt nyreskade
- Hyperglykemi
- Multippel organsvikt
Andre studie-ID-numre
- Prognostic Value of SHR in ICU
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