- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00417105
Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis
Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.
In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.
Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).
It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.
The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- Monash Medical Centre
-
Geelong, Victoria, Australia, 3220
- Geelong Hospital
-
-
-
-
Limburg
-
Hasselt, Limburg, Bélgica, 3500
- Virga Jesse Ziekenhuis
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Bélgica, 3000
- Universitaire Ziekenhuizen Leuven
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age > 18 years
- Maintenance hemodialysis (> 3 months duration)
- Informed consent
Exclusion Criteria:
- No consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
1
hemodialysis twice weekly 4 hours
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
2
nocturnal dialysis twice weekly 8 hours
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
3
nocturnal hemodialysis, 8 hours every other night
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
4
nocturnal hemodialysis, 8 hours, six times per week
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
removal of protein-bound retention solutes
Periodo de tiempo: 1 dialysis session
|
1 dialysis session
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tom Dejagere, MD, Virga Jesse Ziekenhuis
- Investigador principal: Nigel Toussaint, MD, Geelong Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115.
- Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518.
- Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.
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
- NHD001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .