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

This study is currently recruiting participants.
Verified December 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01569698
First received: March 23, 2012
Last updated: December 3, 2012
Last verified: December 2012

March 23, 2012
December 3, 2012
June 2012
June 2014   (final data collection date for primary outcome measure)
extra renal replacement therapy [ Time Frame: at day 60 +/- 3 ] [ 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.
Same as current
Complete list of historical versions of study NCT01569698 on ClinicalTrials.gov Archive Site
  • Current incidence [ Time Frame: at day 60 +/- 3 ] [ 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

Same as current
Not Provided
Not Provided
 
Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Children with an acute renal failure

Kidney Failure, Acute
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.
extrarenal replacement therapy
Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis
Intervention: Procedure: acute extra renal replacement therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
October 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact: Théophile Gaillot, MD +33-299-263-186 theophile.gaillot@chu-rennes.fr
Canada,   France,   Réunion
 
NCT01569698
2010-A00670-39
No
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Theophile Gaillot, MD Rennes University Hospital
Rennes University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP