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

NCT01403220 | Completed

• 2 other identifiers: LOCAL/2011/PJ-022011-A01550-41
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Failure, Acute

Outcome Measures

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.

  12 hours

Secondary Outcomes (6)

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

  24 hours

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

  12 hours

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

  12 hours.

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

  24 hours

• Fluid replacement (yes/no)

  12 hours

Study Arms (2)

Group 1 (hemodiafiltration first)

ACTIVE COMPARATOR

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

Procedure: Hemodiafiltration first

Group 2 (hemofiltration first)

ACTIVE COMPARATOR

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

Procedure: Hemofiltration first

Interventions

Hemodiafiltration first PROCEDURE

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

Group 1 (hemodiafiltration first)

Hemofiltration first PROCEDURE

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

Group 2 (hemofiltration first)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (3)

• 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.

  PMID: 26538503 RESULT

• 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.

  PMID: 28035589 DERIVED

• 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.

  PMID: 27270279 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pascal Jeannes, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: April 1, 2012
• Primary Completion: March 17, 2015
• Study Completion: March 17, 2015
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (1)