Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

Terminated

• Conditions: Kidney Failure, Acute
• Interventions: Procedure: acute extra renal replacement therapy

• Registration Number: NCT01569698
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Study Start: 2012-06
• Primary Completion: 2016-11
• Study Completion: 2019-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
extrarenal replacement therapy	acute extra renal replacement therapy	Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis

Primary Outcome Measures

Name	Time	Method
extra renal replacement therapy	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

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

Trial Locations

Locations (19)

Besançon University Hospital; 🇫🇷 Besançon, France

Pediatry - Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Reanimation pediatric - Morvan Hospital; 🇫🇷 Brest, France

Pediatry - Cote De Nacre University Hospital; 🇫🇷 Caen, France

Pediatric nephrology - Hôpital Couple-enfants; 🇫🇷 Grenoble, France

Pediatric reanimation - Brabois Hospital; 🇫🇷 Vandoeuvre Les Nancy, France

Groupe hospitalier Sud Reunion; 🇷🇪 Reunion, Réunion

Angers University Hospital; 🇫🇷 Angers, France

Bicêtre University Hospital; 🇫🇷 Le Kremlin Bicêtre, France

Pediatric intensive care - Centre mère enfants; 🇨🇦 Sainte-Foy, Canada

Pediatric intensive care -; 🇨🇦 Sherbrooke, Canada

Pediatry - Hopital de la Mère et de l'Enfant; 🇫🇷 Limoges, France

Anesthesy-Pediatric reanimation - Nord University Hospital; 🇫🇷 Marseille, France

Pediatric reanimation - Hôpital mère-enfant; 🇫🇷 Nantes, France

Pediatry - Reims University Hospital; 🇫🇷 Reims, France

Réanimation et Surveillance - Robert Debre Hospital; 🇫🇷 Paris, France

Nephrology - Hôpital des enfants; 🇫🇷 Toulouse, France

Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital; 🇫🇷 Montpellier, France

Nephrology - Pediatric emergency - Clocheville University Hospital; 🇫🇷 Tours, France