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- Ensayo clínico NCT00235521
Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
Comparison of Inhaled Nitric Oxide With Aerosolized Iloprost (Ventavis®) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Investigators, Study Sites: Single-center trial at the Department of Pediatric Cardiology, Department of Cardiac Surgery and Department of Anesthesiology, University Medical Center, Heidelberg, Germany Exploratory proof of concept study (Investigator initiated trial)
Indication: Postoperative pulmonary hypertension in infants and children undergoing cardiopulmonary bypass surgery for intracardiac repair of left-to-right shunt
Objectives: To compare the efficacy of aerosolized iloprost with inhaled nitric oxide to prevent postoperative pulmonary hypertensive crises
Design: Exploratory, open label, randomized study with parallel-group design;
Duration of observation: 72 hours
Population: Infants older than 4 weeks and children less than 18 months of age presenting with left-to-right shunt and increased pulmonary blood flow. Inclusion will be independent on the presence or absence of preoperative pulmonary hypertension
Sample Size:
- 20 patients: inhaled nitric oxide (iNO) - group;
- 20 patients: aerosolized iloprost (ILO) -group
Treatment:
- Both groups: controlled ventilation, sedation, analgetics, inotropic substances as required, standardized intensive care treatment.
- iNO - group: concentration of iNO at 10 ppm; administered by mechanical ventilation.
- ILO - group: aerosolized Iloprost at a dose of 0,5 µg/kg body weight (12x / 24h), administered by ultrasound nebulizer.
Efficacy Parameters: Occurrence of "minor" or "major" pulmonary hypertensive crises (PHTC)
Safety Parameters: Arterial blood pressure, oxygen saturation, complete blood count
Statistical Procedures: All analyses in this exploratory trial are descriptive, giving confidence intervals for differences between treatment groups.
Primary analysis variable: Rate of occurrence of "major" or "minor" pulmonary hypertensive crises
Secondary variables: Presence of hours of pulmonary hypertension, Duration of mechanical ventilation
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Heidelberg, Alemania, 69120
- University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology
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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:
- Informed consent by parents or legal representatives
- Age: Infants older than 4 weeks of age and children less than 1½ years of age.
Presence of a left-to-right shunt with increased pulmonary blood flow. The specific defects that will be present are:
- Aortopulmonary (AP) - Window
- Atrioventricular septal defect (AVSD)
- Double outlet right ventricle (DORV)
- Total anomalous pulmonary venous drainage (TAPVD)
- Truncus arteriosus
- Ventricular septal defect (VSD)
Presence of postoperative PH immediately after intracardiac repair:
- Patients will be enrolled if mean PAP after intracardiac repair exceeds 25 mmHg after weaning from CPB.
Exclusion Criteria:
Specific cardiac defects:
- Atrial septal defect (ASD)
- Cyanotic congenital heart disease
- Univentricular atrio-ventricular - connexion
- Valvular or subvalvular pulmonary or aortic stenosis
Specific circumstances:
- Emergency cardiac surgery
- Children presenting with infection after cardiac surgery
- Infants on extracorporeal membrane oxygenation (ECMO) before cardiac surgery
- Infants/children treated with epoprostenol
Concomitant diseases:
- Systemic arterial hypertension
- Renal failure
- Diabetes mellitus
- Known bleeding disorders (known disorders of blood coagulation and hemostasis)
- Infection during the first 24 hours after cardiac surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Number of pulmonary hypertensive crises (major and/or minor)
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Medidas de resultado secundarias
Medida de resultado |
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Treatment with aerosolized ILO is equally effective as iNO in reducing the pulmonary artery pressure (PAP) within the first 72 hours after cardiopulmonary bypass surgery (CPB)
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Patients treated with aerosolized ILO can be weaned earlier from mechanical ventilation than patients on iNO treatment
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Patients treated with aerosolized ILO show the same in-hospital mortality as patients treated with iNO
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matthias Gorenflo, MD, PhD, Heidelberg University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
- Iloprost-Study
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