Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury (EPURE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01569698|
Recruitment Status : Active, not recruiting
First Posted : April 3, 2012
Last Update Posted : September 11, 2018
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|
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|
|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|
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.
- 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.
- Current incidence [ Time Frame: at day 60 +/- 7 ]Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure
- etiologies [ Time Frame: at day 0 ]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 ]
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
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
|Pediatric intensive care - Centre mère enfants|
|Sainte-Foy, Canada, G1V 4G2|
|Pediatric intensive care -|
|Sherbrooke, Canada, J1H 5N4|
|Angers University Hospital|
|Besançon University Hospital|
|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|
|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|
|Groupe hospitalier Sud Reunion|
|Principal Investigator:||Theophile Gaillot, MD||Rennes University Hospital|