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

17 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Interdialytic Weight Gain
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Hemoglobin Level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Services Institute of Medical Sciences, Pakistan

Investigatori

  • Investigatore principale: Zara Ramzan, Services Institute of Medical Sciences, Pakistan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 maggio 2026

Completamento primario (Stimato)

22 novembre 2026

Completamento dello studio (Stimato)

22 novembre 2026

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ServicesIMSP2

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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