Clinical trial NCT01569698: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
Official title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Failure, Acute
Keywords: pediatric
acute renal failure
acute extra renal replacement therapy
Intermittent Hemodialysis
Continuous Renal Replacement Therapies
Peritoneal Dialysis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 310
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with an acute renal failure

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.

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 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.

Primary outcomes:
measure: extra renal replacement therapy
timeFrame: at day 60 +/- 7
Secondary outcomes:
measure: Current incidence
timeFrame: at day 60 +/- 7
measure: etiologies
timeFrame: at day 0
measure: Risk factors of mortality and non recovery of the renal function
timeFrame: at day 60
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Pediatric intensive care - Centre mère enfants
city: Sherbrooke
country: Canada
facility: Pediatric intensive care -
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Bordeaux
country: France
facility: Pediatry - Bordeaux University Hospital
city: Brest
country: France
facility: Reanimation pediatric - Morvan Hospital
city: Caen
country: France
facility: Pediatry - Cote De Nacre University Hospital
city: Grenoble
country: France
facility: Pediatric nephrology - Hôpital Couple-enfants
city: Le Kremlin Bicêtre
country: France
facility: Bicêtre University Hospital
city: Limoges
country: France
facility: Pediatry - Hopital de la Mère et de l'Enfant
city: Marseille
country: France
facility: Anesthesy-Pediatric reanimation - Nord University Hospital
city: Montpellier
country: France
facility: Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital
city: Nantes
country: France
facility: Pediatric reanimation - Hôpital mère-enfant
city: Paris
country: France
facility: Réanimation et Surveillance - Robert Debre Hospital
city: Reims
country: France
facility: Pediatry - Reims University Hospital
city: Toulouse
country: France
facility: Nephrology - Hôpital des enfants
city: Tours
country: France
facility: Nephrology - Pediatric emergency - Clocheville University Hospital
city: Vandoeuvre Les Nancy
country: France
facility: Pediatric reanimation - Brabois Hospital
city: Reunion
country: Réunion
facility: Groupe hospitalier Sud Reunion
Study officials:
affiliation: Rennes University Hospital
name: Theophile Gaillot, MD
role: PRINCIPAL_INVESTIGATOR
References: