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

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ClinicalTrials.gov Identifier: NCT01403220
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Renal Failure, Acute Procedure: Hemodiafiltration first Procedure: Hemofiltration first Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study
Study Start Date : April 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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?



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403220


Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pascal Jeannes, MD Centre Hospitalier Universitaire de Nîmes