Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
17 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Anmälan via inbjudan
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
64
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Services Institute of Medical Sciences, Lahore
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean Interdialytic Weight Gain
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean Hemoglobin Level
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Baseline and one month after randomization.
|
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Mean Serum Phosphate Level
Tidsram: 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
Tidsram: 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.
|
Baseline and one month after randomization.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Zara Ramzan, Services Institute of Medical Sciences, Pakistan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 maj 2026
Primärt slutförande (Beräknad)
22 november 2026
Avslutad studie (Beräknad)
22 november 2026
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
17 juni 2026
Första postat (Faktisk)
23 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Njursvikt, kronisk
- Njurinsufficiens, kronisk
- Terapeutik
- Kirurgiska ingrepp, operativ
- Sorptionsavgiftning
- Extrakorporeal cirkulation
- Njurersättningsterapi
- Dialys
- Hemofiltrering
- Hemodiafiltrering
Andra studie-ID-nummer
- ServicesIMSP2
Läkemedels- och apparatinformation, studiedokument
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