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CompletedNCT01403220Updated Nov 17, 2025

The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care

An interventional study of Hemodiafiltration first and Hemofiltration first in Renal Failure, Acute, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.

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Conditions studied

  • Renal Failure, Acute

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03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 163 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • According to RIFLE score, patient is stage 'F'
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient meets at least one of the following criteria:
  • metabolic acidosis (pH \< 7.2), excluding keto-acidosis
  • plasma urea > 25 mmol/l
  • hyper-hydration is not controlled by diuretics

Exclusion criteria

Exclusion Criteria:

  • Chronic, terminal renal insufficiency with dialysis
  • The patient is under judicial protection, under tutorship or curatorship
  • Suspect hyperkaliemia (Kaliemia > 6.5 mmol/l with electrocardiographic effects)
  • Intoxications treated via dialysis
  • Pregnant, lactating, parturient women
  • Medical indication for localized citrate anticoagulation
  • dialysis of less than 12 h
  • patient or representative refuses to participate
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
163 participants (actual)

Study arms

  • Active comparator
    Group 1 (hemodiafiltration first)

    This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.

    Procedure: Hemodiafiltration first

  • Active comparator
    Group 2 (hemofiltration first)

    This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.

    Procedure: Hemofiltration first

Interventions

  • ProcedureHemodiafiltration first

    Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.

  • ProcedureHemofiltration first

    Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.

06

What researchers measure

Primary outcomes

  1. Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.

    Proportion of dialysis sequences for which the rate of plasma urea reduction \> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.

    Time frame: 12 hours

Secondary outcomes

  1. Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.

    Proportion of dialysis sequences for which the rate of plasma urea reduction \> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.

    Time frame: 24 hours

  2. Urea clearance (ml/min) for the dialysis sequence under study

    Urea clearance (ml/min) for the dialysis sequence under study.

    Time frame: 12 hours

  3. Filter lifespan (hours) for the dialysis sequence under study.

    Filter lifespan (hours) for the dialysis sequence under study.

    Time frame: 12 hours.

  4. The percentage down-time for the first 24 hours of dialysis

    The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)\*100

    Time frame: 24 hours

  5. Fluid replacement (yes/no)

    Was fluid replacement necessary during the studied dialysis sequence?

    Time frame: 12 hours

  6. Fluid replacement (yes/no)

    Was fluid replacement necessary during the studied dialysis sequence?

    Time frame: 24 hours

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Nîmes
    Nîmes, Gard 30029, France
08

References and documents

Publications

  • Roger C, Muller L, Wallis SC, Louart B, Saissi G, Lipman J, Lefrant JY, Roberts JA. Population pharmacokinetics of linezolid in critically ill patients on renal replacement therapy: comparison of equal doses in continuous venovenous haemofiltration and continuous venovenous haemodiafiltration. J Antimicrob Chemother. 2016 Feb;71(2):464-70. doi: 10.1093/jac/dkv349. Epub 2015 Nov 3. PubMed 26538503 ↗
  • Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z. PubMed 28035589 ↗
  • Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug. PubMed 27270279 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01403220
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jul 27, 2011
Start date
Apr 2012
Primary completion
Mar 17, 2015
Completion
Mar 17, 2015
Last update
Nov 17, 2025

Study contacts

Pascal Jeannes, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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