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

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ClinicalTrials.gov Identifier: NCT01569698
Recruitment Status : Active, not recruiting
First Posted : April 3, 2012
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

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 or disease Intervention/treatment
Kidney Failure, Acute Procedure: acute extra renal replacement therapy

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.


Study Type : Observational
Actual Enrollment : 310 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
Study Start Date : June 2012
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : January 2019

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. extra renal replacement therapy [ Time Frame: at day 60 +/- 7 ]
    To describe usual modalities of pediatric acute extra renal replacement therapy including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis.


Secondary Outcome Measures :
  1. Current incidence [ Time Frame: at day 60 +/- 7 ]
    Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure

  2. etiologies [ Time Frame: at day 0 ]
    Acute kidney injury etiologies leading to extra renal replacement therapy

  3. Risk factors of mortality and non recovery of the renal function [ Time Frame: at day 60 ]

    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




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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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): NCT01569698


Locations
Canada
Pediatric intensive care - Centre mère enfants
Sainte-Foy, Canada, G1V 4G2
Pediatric intensive care -
Sherbrooke, Canada, J1H 5N4
France
Angers University Hospital
Angers, France
Besançon University Hospital
Besançon, France
Pediatry - Bordeaux University Hospital
Bordeaux, France, 33076
Reanimation pediatric - Morvan Hospital
Brest, France, 29609
Pediatry - Cote De Nacre University Hospital
Caen, France, 14000
Pediatric nephrology - Hôpital Couple-enfants
Grenoble, France, 38043
Bicêtre University Hospital
Le Kremlin Bicêtre, France
Pediatry - Hopital de la Mère et de l'Enfant
Limoges, France, 87000
Anesthesy-Pediatric reanimation - Nord University Hospital
Marseille, France, 13920
Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital
Montpellier, France
Pediatric reanimation - Hôpital mère-enfant
Nantes, France, 44093
Réanimation et Surveillance - Robert Debre Hospital
Paris, France, 75007
Pediatry - Reims University Hospital
Reims, France, 51092
Nephrology - Hôpital des enfants
Toulouse, France, 31059
Nephrology - Pediatric emergency - Clocheville University Hospital
Tours, France, 37044
Pediatric reanimation - Brabois Hospital
Vandoeuvre Les Nancy, France, 54511
Réunion
Groupe hospitalier Sud Reunion
Reunion, Réunion
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Theophile Gaillot, MD Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01569698     History of Changes
Other Study ID Numbers: 2010-A00670-39
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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