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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure, Acute
• Intervention / Treatment: Procedure: Hemodiafiltration first; Procedure: Hemofiltration first

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nīmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
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; Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
Urea clearance (ml/min) for the dialysis sequence under study	Urea clearance (ml/min) for the dialysis sequence under study.	12 hours
Filter lifespan (hours) for the dialysis sequence under study.	Filter lifespan (hours) for the dialysis sequence under study.	12 hours.
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	24 hours
Fluid replacement (yes/no)	Was fluid replacement necessary during the studied dialysis sequence?	12 hours
Fluid replacement (yes/no)	Was fluid replacement necessary during the studied dialysis sequence?	24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pascal Jeannes, MD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 17, 2015
• Study Completion (Actual): March 17, 2015

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimated): July 27, 2011

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: LOCAL/2011/PJ-02; 2011-A01550-41 (Other Identifier: ANSM)