Prevention of Contrast Induced Nephropathy by Erythropoietin
Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.
The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).
The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Nahariya, Israel
- Reclutamiento
- Western Galilee Hospital
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Contacto:
- Shaul Atar, MD
- Correo electrónico: shaul.atar@naharia.health.gov.il
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Contacto:
- Batya Kristal, MD
- Correo electrónico: batya.kristal@naharia.health.gov.il
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Investigador principal:
- Shaul Atar, MD
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Investigador principal:
- Batya Kristal, MD
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Sub-Investigador:
- Lilach Shema-Didi, RN, MPH
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Sub-Investigador:
- Irith Weissman, MD
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Sub-Investigador:
- Ronit Geron, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Over 18 years of age.
- Diabetic patients.
- eGFR < 60 ml/min/1.73m2.
- Scheduled for primary or elective PCI.
Exclusion Criteria:
- Non diabetic patients.
- Patients with eGFR ≥ 60 ml/min/1.73m2.
- Chronic renal replacement therapy.
- Subject with active malignancy.
- Subject with any known history of seizure disorders.
- Subject with polycythemia.
- Uncontrolled hypertension.
- Known allergy or hypersensitivity to EPO.
- Use of EPO 1 week prior to randomization.
- Use of long acting EPO (CERA) during 1 month prior to randomization.
- Use of NAC or bicarbonate during 3 days prior to randomization.
- Contrast media exposure during the last 7 days before randomization.
- Pregnant or lactating women.
- Participation in other clinical trial.
- Refusal or inability to give informed consent due to mental or physical state.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
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normal saline intravenously
Otros nombres:
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Experimental: Erythropoietin
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50,000U intravenously
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of Contrast Induced Nephropathy(CIN)
Periodo de tiempo: 1-3 days after exposure to contrast media
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1-3 days after exposure to contrast media
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Enzymatic infarct size
Periodo de tiempo: 6h and 12 h after exposure to contrast media
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Will be measured by Troponin and CK
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6h and 12 h after exposure to contrast media
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Hospital length of stay
Periodo de tiempo: participants will be followed for the duration of hospital stay, an expected average of 3 days
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participants will be followed for the duration of hospital stay, an expected average of 3 days
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Renal replacement therapy
Periodo de tiempo: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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Hospital mortality
Periodo de tiempo: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shaul Atar, MD, Western Galilee Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- EPO1
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