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Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters

17 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

64

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Services Institute of Medical Sciences, Lahore

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: Conventional Hemodialysis
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.
Experimenteel: 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.
Ander: Hemodiafiltration
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Interdialytic Weight Gain
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Hemoglobin Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.
Mean C-Reactive Protein Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.
Mean Serum Albumin Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.
Mean Total Cholesterol Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.
Mean Serum Calcium Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.
Mean Serum Phosphate Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.
Mean Intact Parathyroid Hormone Level
Tijdsspanne: Baseline and one month after randomization.
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.
Baseline and one month after randomization.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Services Institute of Medical Sciences, Pakistan

Onderzoekers

  • Hoofdonderzoeker: Zara Ramzan, Services Institute of Medical Sciences, Pakistan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 mei 2026

Primaire voltooiing (Geschat)

22 november 2026

Studie voltooiing (Geschat)

22 november 2026

Studieregistratiedata

Eerst ingediend

10 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ServicesIMSP2

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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