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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01403220
First received: July 25, 2011
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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 Intervention
Renal Failure, Acute
Procedure: Hemodiafiltration first
Procedure: Hemofiltration first

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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:
  • Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

  • Urea clearance (ml/min) for the dialysis sequence under study [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Urea clearance (ml/min) for the dialysis sequence under study.

  • Filter lifespan (hours) for the dialysis sequence under study. [ Time Frame: 12 hours. ] [ Designated as safety issue: No ]
    Filter lifespan (hours) for the dialysis sequence under study.

  • The percentage down-time for the first 24 hours of dialysis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)*100

  • Fluid replacement (yes/no) [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
    Was fluid replacement necessary during the studied dialysis sequence?

  • Fluid replacement (yes/no) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Was fluid replacement necessary during the studied dialysis sequence?


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403220

Contacts
Contact: Pascal Jeannes, Md +33.(0)4.66.68.30.50 pascal.jeannes@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Pascal Jeannes, MD         
Sub-Investigator: Benjamin Conte         
Sub-Investigator: Jean-Yves Lefrant, MD PhD         
Sub-Investigator: Christian Bengler, MD         
Sub-Investigator: Charles Arich, MD         
Sub-Investigator: Geoffroy Dingemans, MD         
Sub-Investigator: Caroline Boutin, MD         
Sub-Investigator: Guillaume Louart, MD         
Sub-Investigator: Laurent Muller, MD         
Sub-Investigator: Robert Cohendy, MD         
Sub-Investigator: Patrice Poupard, MD         
Sub-Investigator: Pierre Barbaste, Md         
Sub-Investigator: Gilbert Saissi, MD         
Sub-Investigator: Ghislaine Gardes, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pascal Jeannes, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01403220     History of Changes
Other Study ID Numbers: LOCAL/2011/PJ-02
Study First Received: July 25, 2011
Last Updated: April 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014