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- Ensayo clínico NCT01228279
Sympathetic Activity in Patients With End-stage Renal Disease on Peritoneal Dialysis (SAPD)
Effects of Non-Glucose-Based Peritoneal Dialysis Solution "EXTRANEAL" on Changes in Leptin Levels and Sympathetic Activity Induced by Conventional Glucose-Based Dialysate "DIANEAL" in Patients on Peritoneal Dialysis
Hypothesis:
Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic activity in response to an increase in leptin and insulin. Converting patients from a regimen of only glucose containing dialysate to a regimen with non-glucose-based solution, icodextrin, will reduce the insulin and leptin levels and will reverse dialysis-induced increases in sympathetic activity.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Cardiovascular mortality remains higher among patients treated with peritoneal dialysis as compared to patients treated with hemodialysis. Sympathetic hyperactivity is considered a significant emerging risk factor for cardiovascular mortality among patients with ESRD (End-Stage Renal Disease). Sympathetic activity, via its hemodynamic effects and trophic effects, and in interaction with RAAS (Renin Angiotensin Aldosterone System), does play a major role in cardiac and vascular remodelling, development of LVH and vascular hypertrophy, as well as progression to CHF. Glucose-based dialysate induces hyperinsulinemia and hyperleptinemia. We propose that hyperleptinemia induced by glucose-based peritoneal solution is a significant contributing factor to sympathetic hyperactivity in ESRD patients treated with PD, and could be prevented by non-glucose-based PD solution such as icodextrin-based.
Adult patients with ESRD starting PD as their first renal replacement therapy modality will be studied. Patients will be recruited 1-3 weeks prior to starting PD treatment. At baseline, specific studies for microneurography (MSNA), fasting plasma insulin, leptin, catecholamines and brain natriuretic peptide (BNP) will be performed. EKG will be recorded and digitized for further assessment of heart rate variability using power spectral analysis. Extracellular fluid volume status will be assessed by bioelectrical impedance. Central vascular volume will be assessed from inferior vena cava (IVC) by heart ultrasound. Consequently 24-h ambulatory blood pressure monitoring(ABPM)and a 24-h urine collection for urea clearance and creatinine clearance will be done.
All participants into the study will receive a PD treatment for 6 weeks with standard glucose-based PD solution Dianeal. The specific studies are repeated at 6 weeks.Then, patients will be randomized to one of the two groups (arms). One group will continue with Dianeal PD solution for another 12 weeks. The other group will receive Dianeal during the day and Extraneal, icodextrin or non-glucose based solution, during the night only, for the next 12 weeks. The specific studies are repeated at 12 weeks after randomization (18 weeks of PD treatment).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá
- Ottawa Hospital Research Institute
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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:
- Adult (age 18 years and older)
- Patients with end-stage renal disease(ESRD)/chronic kidney disease(CKD)stage 5
Exclusion Criteria:
- Diabetes Mellitus
- Acute coronary syndrome in the past 6 months
- Cardiac arrhythmias (2nd and 3rd degree heart block or premature ventricular complexes in Lown classes 4 or 5)
- Symptoms suggestive of obstructive or central sleep apnea (with a score of > 10 on Epworth sleepiness scale)
- Patients taking Clonidine
- Body mass index (BMI) > 34
- Patients unable to give consent
- Pregnant women
- Patients with leg injury involving nerve damage
- Patients taking anticoagulant medication
- Patients with significant bleeding disorder or liver disorder
- Hemoglobin <1.05 g/dl at the time of initiation of therapy
- patients with unilateral or bilateral nephrectomy
- Planned kidney transplant in the next 4 months
- Life expectancy under 6 months
- Oliguria (urine output less than 400 ml per day)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: DIANEAL
One group of patients will start peritoneal dialysis with the glucose-based solution (DIANEAL) for 6 weeks, then will continue with the same type of solution for another 12 weeks.
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Weeks 1 to 6 (6 weeks):
Weeks 7 to 18 (12 weeks): *same regimen as weeks 1 to 6, for both CAPD and CCPD patients
Otros nombres:
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Comparador activo: EXTRANEAL
The other group of patients will start peritoneal dialysis with the glucose-based solution (DIANEAL) for 6 weeks, then will continue with DIANEAL solution during the day and the non-glucose-based solution, EXTRANEAL, during the night
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Weeks 1 to 6 (6 weeks):
Weeks 7 to 18 (12 weeks):
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in muscle sympathetic nerve activity(MSNA)
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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Muscle sympathetic nerve activity(MSNA) is measured by microneurography at
MSNA increases on a glucose-based dialysis regimen and may decrease by adding non-glucose-based solution |
6 weeks on PD and 18 weeks on PD
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Changes in leptin levels
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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Plasma leptin increases on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
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6 weeks on PD and 18 weeks on PD
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in blood pressure as assessed from 24-hour ambulatory blood pressure monitor (ABPM)
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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Blood pressure will be assessed with 24-hour ABPM at baseline, 6 weeks on PD and 18 weeks after starting peritoneal dilaysis.
Summary measures of each day and night period include average systolic and diastolic BP as well as % nocturnal dipping.
These summary measures can predict cardiovascular events more accurately than casual BP measures
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6 weeks on PD and 18 weeks on PD
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Changes in extracellular volume assessed by bioelectrical impedance (BIA)
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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Bioelectrical impedance directly measures extracellular fluid volume and total body water.
The test is based on the ability to detect differences in the conductive properties of a cell by measuring its resistance (impedance) to electrical current.
The technique is reliable for tracking sequential changes in extracellular fluid volume.
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6 weeks on PD and 18 weeks on PD
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Changes in heart rate variability
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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During the microneurography testing, EKG is recorded.
Heart rate and heart rate variability(HRV) will be analyzed from EKG data at baseline, 6 weeks and 18 weeks after starting dialysis.
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6 weeks on PD and 18 weeks on PD
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Changes in central intravascular volume assessed by cardiac ultrasound
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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Central intravascular volume will be assessed by measuring inferior vena cava (IVC) diameter during cardiac ultrasound at baseline, 6 weeks and 18 weeks on dialysis treatment
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6 weeks on PD and 18 weeks on PD
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Changes in plasma catecholamines levels
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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*Plasma catecholamines (epinephrine and norepinephrine) increase on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
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6 weeks on PD and 18 weeks on PD
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Changes in BNP (Brain Natriuretic Peptide)levels
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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*Brain Natriuretic Peptide (BNP)increases on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
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6 weeks on PD and 18 weeks on PD
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Changes in plasma insulin levels
Periodo de tiempo: 6 weeks on PD and 18 weeks on PD
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*Plasma insulin increases on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
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6 weeks on PD and 18 weeks on PD
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Marcel Ruzicka, MD, PHD, Ottawa Hospital Research Institute
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 (Estimar)
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
Otros números de identificación del estudio
- NA6951
Información sobre medicamentos y dispositivos, documentos del estudio
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