Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury (EPURE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01569698
First received: March 23, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.

In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.

This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.


Condition Intervention
Kidney Failure, Acute
Procedure: acute extra renal replacement therapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • extra renal replacement therapy [ Time Frame: at day 60 +/- 7 ] [ Designated as safety issue: No ]
    To describe usual modalities of pediatric acute extra renal replacement therapy including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis.


Secondary Outcome Measures:
  • Current incidence [ Time Frame: at day 60 +/- 7 ] [ Designated as safety issue: No ]
    Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure

  • etiologies [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
    Acute kidney injury etiologies leading to extra renal replacement therapy

  • Risk factors of mortality and non recovery of the renal function [ Time Frame: at day 60 ] [ Designated as safety issue: No ]

    Risk factors of mortality and non recovery of the renal function at day 60 in child acute kidney injur treated by extra renal replacement therapy (including, among others, the choice of dialysis modality (i.e. Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis), the indications for and timing of dialysis intervention, and the dose of dialysis).

    Urea, blood pressure, creatinine, report proteinuria / creatinuria, renal disease, acute graft



Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
extrarenal replacement therapy
Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis
Procedure: acute extra renal replacement therapy
usual modalities of pediatric acute extra renal replacement therapy : Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis
Other Name: Non applicable.

Detailed Description:

In children, there are limited data on extra renal replacement therapy. Pediatric studies are often retrospective, or often limited to specific disease processes or specific extra renal therapy. The lack of large studies including different usual modalities in pediatrics limits any formal recommendation on use in relation to patient outcomes, including renal recovery and mortality. Some of the issues that need consideration are the choice of dialysis modality (including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis), the indications for and timing of dialysis intervention, the dose of dialysis and their effects on outcomes from acute kidney injury in children.

This study will supply important data about pediatric acute extra renal replacement therapy, including the epidemiology of pediatric acute kidney injury leading to extra renal replacement therapy, the variety of the treatment modalities, and their effects on the course of the disease.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with an acute renal failure

Criteria

Inclusion Criteria:

  • Age < 18 years, including the newborn ;
  • Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method.

Exclusion Criteria:

  • Treatment by extra renal replacement therapy for terminal renal failure;
  • History of renal transplantation;
  • Extra renal replacement therapy for an inborn errors of metabolism without acute renal failure;
  • Extra renal replacement therapy in the context of a drug intoxication without acute renal failure;
  • Treatment by technique in MARS (Molecular Adsorbent Recirculating System);
  • Modified ultrafiltration during surgery.
  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: NCT01569698

Contacts
Contact: Théophile Gaillot, MD +33-299-263-186 theophile.gaillot@chu-rennes.fr

Locations
Canada
Pediatric intensive care - Centre mère enfants Recruiting
Sainte-Foy, Canada, G1V 4G2
Contact: Dennis Bailey, MD       dennis.bailey@mail.chuq.qc.ca   
Principal Investigator: Dennis Bailey, MD         
Sub-Investigator: Philippe Jouvet, MD         
Sub-Investigator: Véronique Phan, MD         
Pediatric intensive care - Recruiting
Sherbrooke, Canada, J1H 5N4
Contact: Miriam Santschi, MD       miriamsantschi@yahoo.com   
Principal Investigator: Miriam Santschi, MD         
Sub-Investigator: Valérie Bertelle, MD         
France
Angers University Hospital Recruiting
Angers, France
Contact: Gerard Champion, MD       Gechampion@chu-angers.fr   
Principal Investigator: Gerard Champion, MD         
Besançon University Hospital Recruiting
Besançon, France
Contact: François Nobili, MD       fnobili@chu-besancon.fr   
Principal Investigator: François Nobili, MD         
Pediatry - Bordeaux University Hospital Recruiting
Bordeaux, France, 33076
Contact: Jérôme Harambat, MD       jerome.harambat@chu-bordeaux.fr   
Principal Investigator: Jérôme Harambat, MD         
Reanimation pediatric - Morvan Hospital Recruiting
Brest, France, 29609
Contact: Armelle Garenne, MD       armelle.garenne@chu-brest.fr   
Principal Investigator: Armelle Garenne, MD         
Pediatry - Cote De Nacre University Hospital Recruiting
Caen, France, 14000
Contact: Philippe Eckart, MD       eckart-p@chu-caen.fr   
Principal Investigator: Philippe Eckart, MD         
Pediatric nephrology - Hôpital Couple-enfants Recruiting
Grenoble, France, 38043
Contact: Guylhène Bourdat-Michel, MD       gbourdatmichel@chu-grenoble.fr   
Principal Investigator: Guylhène Bourdat-Michel, MD         
Bicêtre University Hospital Recruiting
Le Kremlin Bicêtre, France
Contact: Laurent Chevret, MD       laurent.chevret@bct.aphp.fr   
Principal Investigator: Laurent Chevret, MD         
Pediatry - Hopital de la Mère et de l'Enfant Recruiting
Limoges, France, 87000
Contact: Vincent Guigonis, MD       v.guigonis@gmail.com   
Principal Investigator: Vincent Guigonis, MD         
Anesthesy-Pediatric reanimation - Nord University Hospital Recruiting
Marseille, France, 13920
Contact: Fabrice Michel, MD       fabrice.michel@ap-hm.fr   
Principal Investigator: Fabrice Michel, MD         
Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital Recruiting
Montpellier, France
Contact: Denis Morin, MD       d-morin@chu-montpellier.fr   
Principal Investigator: Denis Morin, MD         
Pediatric reanimation - Hôpital mère-enfant Recruiting
Nantes, France, 44093
Contact: Jean-Michel Liet, MD       jeanmichel.liet@chu-nantes.fr   
Principal Investigator: Jean-Michel Liet, MD         
Sub-Investigator: Gwenaelle Roussey, MD         
Réanimation et Surveillance - Robert Debre Hospital Recruiting
Paris, France, 75007
Contact: Stéphane Dauger, MD       stephane.dauger@rdb.aphp.fr   
Principal Investigator: Stéphane Dauger, MD         
Pediatry - Reims University Hospital Recruiting
Reims, France, 51092
Contact: Christine Piétrement, MD       cpietrement@chu-reims.fr   
Principal Investigator: Christine Piétrement, MD         
Sub-Investigator: Sahar Bayat Makoei, MD         
Sub-Investigator: Gilbert Landthaler, MD         
Sub-Investigator: Marie-Pierre Lavocat, MD         
Nephrology - Hôpital des enfants Recruiting
Toulouse, France, 31059
Contact: Arnaud Garnier, MD       garnier.a@chu-toulouse.fr   
Principal Investigator: Arnaud Garnier, MD         
Sub-Investigator: Hubert Nivet, MD         
Sub-Investigator: JULIE CHANTREUIL, MD         
Sub-Investigator: NICOLAS ROULLET RENOLEAU, MD         
Sub-Investigator: THIERRY PEREZ, MD         
Nephrology - Pediatric emergency - Clocheville University Hospital Recruiting
Tours, France, 37044
Contact: Sylvie Cloarec, MD       S.CLOAREC@chu-tours.fr]   
Principal Investigator: Sylvie Cloarec, MD         
Sub-Investigator: Tim Ulinski, MD         
Sub-Investigator: Michelle Hall, MD         
Sub-Investigator: Laure Collard, MD         
Sub-Investigator: Johan Vandewalle, MD         
Sub-Investigator: Paloma Parvex, MD         
Sub-Investigator: Peter Rimensberger, MD         
Pediatric reanimation - Brabois Hospital Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Florent Girard, MD       f.girard@chu-nancy.fr   
Principal Investigator: Florent Girard, MD         
Réunion
Groupe hospitalier Sud Reunion Recruiting
Reunion, Réunion
Contact: Benjamin Dusang, MD       benjamin.dusang@chr-reunion.fr   
Sub-Investigator: Benjamin Dusang, MD         
Principal Investigator: Hugues Flodrops, MD         
Sub-Investigator: Audrey Breining, MD         
Sub-Investigator: Michel Tsimaratos, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Theophile Gaillot, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01569698     History of Changes
Other Study ID Numbers: 2010-A00670-39
Study First Received: March 23, 2012
Last Updated: June 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
pediatric
acute renal failure
acute extra renal replacement therapy
Intermittent Hemodialysis
Continuous Renal Replacement Therapies
Peritoneal Dialysis

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

ClinicalTrials.gov processed this record on October 23, 2014