- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04196322
Hyperglycemia as a Prognostic Factor In Acute Ischemic Stroke Patients
Background: Hyperglycemia is encountered in 20% to 40% of acute stroke patients, with or without a pre-morbid diagnosis of diabetes mellitus. Hyperglycemia is a risk factor for infarct expansion and poor outcome through the first 72 hours of onset in both diabetics and non-diabetics patients. This study was done to evaluate the glycemic status after acute ischemic stroke and assess its rule in influencing stroke outcome as regards the duration of hospital stay, motor deficit and mortality.
Methods: This retrospective study was conducted in Elzaiton specialized hospital from June 2016 to June 2017on 80 patients after approval of local medical ethical committee. Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were included and divided into two groups, controlled group (Random blood suger not more than 150 mg/dl) and uncontrolled group ( Random blood suger more than 150 mg/dl). All patients were evaluated for GCS as a primary outcome and for hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors,hospital stay and mortality as secondary outcomes.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Patients and Methods This study was prospective study conducted in Elzaiton specialized hospital and Ain Shams University from june2016 to June 2017on 80 patients after approval of local medical ethical committee
All patients was subjected to the following
- Full clinical history …age, sex, weight and medical history
- GCS and motor deficit
- Random blood glucose level at admission and 4-6 times daily during hospital stay
- HbA1c on admission
- Hemodynamic monitoring
- Duration of hospital stay
- Thirty day mortality
- Other laboratory investigation to rule out other similar cause
- Follow up hemorrhagic transformation Study tools: Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms will be evaluated.
On ICU admission the random blood sugar was recorded and categorized to less than 150mg/dl (accepted) and more than 150mg/dl(not controlled). Also serial Random blood sugar daily was recorded and categorized to accepted or good control if less than 150mg/dl and not controlled if more than 150mg/dl.
Patients were divided into 2 groups Patients with accepted random blood sugar at admission and controlled blood sugar during hospital stay.
Patients with increased random blood sugar at admission and poor blood sugar control during hospital stay.
These data were collected and patients were observed as regards duration of hospital stay,hemorrhagic transformation, hospital stay duration and 30-days mortality
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ain Shams University Specialized Hospital
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Cairo, Ain Shams University Specialized Hospital, Egipto
- Hanaa El Gendy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms will be evaluated.
At ICU admission the random blood sugar was recorded and categorized to less than 150mg/dl (accepted) and more than 150mg/dl(not controlled). Also serial Random blood sugar daily was recorded and categorized to accepted or good control if less than 150mg/dl and not controlled if more than 150mg/dl.
Patients were divided into 2 groups Patients with accepted random blood sugar at admission and controlled blood sugar during hospital stay (B) Patients with increased random blood sugar at admission and poor blood sugar control during hospital stay These data were collected and patients were observed as regards duration of hospital stay, motor deficit improvement or worsening using Rating scale for muscle strength
Descripción
Inclusion criteria
- Age: 40-70years
- Sex: Any sex
- Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were evaluated.
Exclusion criteria
- Subdural heamatoma, metabolic causes or transient ischemic attack
- Sub arachnoid heamorrage
- Heamorragic stroke
- Patients with major comorbidities at admission as end stage liver disease, end stage renal disease and malignant hypertension
- Patients with hyperglycemia at admission and controlled blood sugar during hospital stay
- Patients with DKA or hypoglycemia (RBS less than 70 mg dl)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Controlled
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estudio observacional
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Uncontrolled
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estudio observacional
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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GCS
Periodo de tiempo: 30 days
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GCS was assessed for 30 days
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30 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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30 días de mortalidad
Periodo de tiempo: 30 dias
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30 días de mortalidad
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30 dias
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Isquemia cerebral
- Infarto
- Infarto cerebral
- Hiperglucemia
- Carrera
- Accidente cerebrovascular isquémico
- Isquemia
- Infarto cerebral
Otros números de identificación del estudio
- El Zaitoun Specialized Hospita
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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