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NCT Number: NCT01403220

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

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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Key information

Conditions

Renal Failure, Acute Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Hemodiafiltration first

Procedure

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

Hemofiltration first

Procedure

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

Primary outcomes

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

    Time frame: 12 hours

    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.

Secondary outcomes

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

    Time frame: 24 hours

    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.

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

    Time frame: 12 hours

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

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

    Time frame: 12 hours.

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

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

    Time frame: 24 hours

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

  5. Fluid replacement (yes/no)

    Time frame: 12 hours

    Was fluid replacement necessary during the studied dialysis sequence?

  6. Fluid replacement (yes/no)

    Time frame: 24 hours

    Was fluid replacement necessary during the studied dialysis sequence?

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2011
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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