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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With In-Hospital ICU Mortality
Periodo de tiempo: Up to 30 days
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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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Atributos de la enfermedad
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Insuficiencia renal
- Choque
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Enfermedad crítica
- Lesión renal aguda
- Hiperglucemia
- Fallo multiorgánico
Otros números de identificación del estudio
- Prognostic Value of SHR in ICU
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