Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

Kidney Failure, Acute Clinical Trial

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Official title:

Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01569698
• Other study ID #: 2010-A00670-39
• Status: Terminated
• Start date: June 2012
• Est. completion date: July 2019

Study information

• Verified date: April 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 310
• Est. completion date: July 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Procedure:
• acute extra renal replacement therapy
usual modalities of pediatric acute extra renal replacement therapy : Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis

Locations

Country	Name	City	State
Canada	Pediatric intensive care - Centre mère enfants	Sainte-Foy
Canada	Pediatric intensive care -	Sherbrooke
France	Angers University Hospital	Angers
France	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	Bicêtre University Hospital	Le Kremlin Bicêtre
France	Pediatry - Hopital de la Mère et de l'Enfant	Limoges
France	Anesthesy-Pediatric reanimation - Nord University Hospital	Marseille
France	Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital	Montpellier
France	Pediatric reanimation - Hôpital mère-enfant	Nantes
France	Réanimation et Surveillance - Robert Debre Hospital	Paris
France	Pediatry - Reims University Hospital	Reims
France	Nephrology - Hôpital des enfants	Toulouse
France	Nephrology - Pediatric emergency - Clocheville University Hospital	Tours
France	Pediatric reanimation - Brabois Hospital	Vandoeuvre Les Nancy
Réunion	Groupe hospitalier Sud Reunion	Reunion

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Countries where clinical trial is conducted

Canada,  France,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Current incidence	Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure	at day 60 +/- 7
Secondary	etiologies	Acute kidney injury etiologies leading to extra renal replacement therapy	at day 0
Secondary	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