Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
17 de junio de 2026 actualizado por: Rameen Masood, Services Institute of Medical Sciences, Pakistan
A Randomized Clinical Trial Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
Chronic kidney disease may progress to end-stage renal disease, a stage in which the kidneys will no longer be able to adequately remove extra fluid and waste products from the body. Many patients with end-stage renal disease will require regular dialysis to survive. Conventional hemodialysis is the most commonly used dialysis technique and will mainly remove waste products through diffusion. Hemodiafiltration is another dialysis technique that will combine diffusion with convection and may help remove a wider range of waste substances from the blood.
This randomized clinical trial will compare hemodiafiltration with conventional hemodialysis in adult patients with end-stage renal disease who are already receiving maintenance dialysis. Eligible participants will be assigned by random allocation to either conventional hemodialysis or hemodiafiltration. Both treatments will be provided as part of routine dialysis care, and no experimental drug will be used.
The main purpose of the study will be to determine whether hemodiafiltration will lead to better fluid control compared with conventional hemodialysis. Fluid control will be assessed by measuring the average weight gained between dialysis sessions over a four-week period. The study will also compare selected blood test parameters between the two groups after one month, including hemoglobin, C-reactive protein, serum albumin, total cholesterol, serum calcium, serum phosphate, and intact parathyroid hormone.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Services Institute of Medical Sciences, Lahore
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adult patients aged 18-70 years.
- Both male or female.
- End-stage kidney disease as per operational definition.
- On a stable dialysis prescription for at least 3 months, with thrice-weekly sessions (or unit-standard schedule) and stable dry weight assessment.
- Clinically stable over the preceding 4 weeks, with no hospitalization or acute intercurrent illness.
Exclusion Criteria:
- Cardiovascular instability: recurrent intradialytic hypotension (≥30% of sessions in the prior month requiring saline or early termination), uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg despite therapy), recent acute coronary syndrome, stroke, or decompensated heart failure within 3 months.
- Advanced hepatic disease (decompensated cirrhosis or refractory ascites), active systemic infection, chronic inflammatory disease flare, or active malignancy under treatment likely to confound fluid status or survival.
- Recent blood transfusion within the preceding 4 weeks, or active bleeding, as these may distort hemoglobin and inflammatory indices.
- Advanced chronic liver disease, nephrotic-range protein loss, or other conditions likely to substantially alter serum albumin independent of dialysis modality.
- Parathyroidectomy history or current use of intravenous calcimimetics initiation/change within the preceding 4 weeks, if expected to markedly alter intact parathyroid hormone.
- Adherence concerns: documented inability to follow fluid/salt advice or to attend scheduled treatments during the screening period; anticipated surgery or hospitalization within the study window.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group A Conventional Hemodialysis
Participants assigned to this group will receive conventional bicarbonate hemodialysis as per routine departmental dialysis protocol.
Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice.
Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.
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Conventional bicarbonate hemodialysis will be performed as part of routine maintenance dialysis care.
This technique will primarily remove solutes through diffusion across a semipermeable dialysis membrane, with ultrafiltration for fluid removal.
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Experimental: Group B Hemodiafiltration
Participants assigned to this group will receive hemodiafiltration as per routine departmental dialysis protocol.
Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice.
Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.
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Hemodiafiltration will be performed as part of routine maintenance dialysis care.
This technique will combine diffusive and convective solute removal, using replacement fluid according to departmental protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Interdialytic Weight Gain
Periodo de tiempo: Baseline and one month after randomization.
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Mean interdialytic weight gain will be assessed in kilograms.
For each dialysis session, interdialytic weight gain will be calculated as the pre-dialysis weight of the current session minus the post-dialysis weight of the immediately preceding session.
Body weight will be measured using a calibrated digital scale in the dialysis unit.
Session-level interdialytic weight gain values will be recorded throughout the follow-up period, and the mean value for each participant will be calculated by dividing the total interdialytic weight gain by the number of attended dialysis sessions.
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Baseline and one month after randomization.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Hemoglobin Level
Periodo de tiempo: Baseline and one month after randomization.
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Hemoglobin level will be measured in g/dL using routine hospital laboratory testing.
The mean hemoglobin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean C-Reactive Protein Level
Periodo de tiempo: Baseline and one month after randomization.
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C-reactive protein level will be measured in mg/L using routine hospital laboratory testing.
The mean C-reactive protein level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Serum Albumin Level
Periodo de tiempo: Baseline and one month after randomization.
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Serum albumin level will be measured in g/dL using routine hospital laboratory testing.
The mean serum albumin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Total Cholesterol Level
Periodo de tiempo: Baseline and one month after randomization.
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Total cholesterol level will be measured in mg/dL using routine hospital laboratory testing.
The mean total cholesterol level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Serum Calcium Level
Periodo de tiempo: Baseline and one month after randomization.
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Total serum calcium level will be measured in mg/dL using routine hospital laboratory testing.
The mean serum calcium level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Serum Phosphate Level
Periodo de tiempo: Baseline and one month after randomization.
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Serum phosphate level will be measured in mg/dL using routine hospital laboratory testing.
The mean serum phosphate level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Intact Parathyroid Hormone Level
Periodo de tiempo: Baseline and one month after randomization.
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Intact parathyroid hormone level will be measured in pg/mL using routine hospital laboratory testing.
The mean intact parathyroid hormone level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Zara Ramzan, Services Institute of Medical Sciences, Pakistan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de mayo de 2026
Finalización primaria (Estimado)
22 de noviembre de 2026
Finalización del estudio (Estimado)
22 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
- Insuficiencia Renal Crónica
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Desintoxicación de sorción
- Circulación extracorpórea
- Terapia de reemplazo renal
- Diálisis Renal
- Hemofiltración
- Hemodiafiltración
Otros números de identificación del estudio
- ServicesIMSP2
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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