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

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.

Study Overview

• Status: Terminated
• Conditions: Kidney Failure, Acute
• Intervention / Treatment: 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
• Enrollment (Actual): 310

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with an acute renal failure

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Non applicable.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current incidence	Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure	at day 60 +/- 7
etiologies	Acute kidney injury etiologies leading to extra renal replacement therapy	at day 0
Risk factors of mortality and non recovery of the renal function	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	at day 60

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Theophile Gaillot, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 3, 2012

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: pediatric; Peritoneal Dialysis; Intermittent Hemodialysis; acute renal failure; acute extra renal replacement therapy; Continuous Renal Replacement Therapies
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2010-A00670-39