Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

NCT ID: NCT01569698

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 310 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-07-31

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.

Conditions

Kidney Failure, Acute

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

extrarenal replacement therapy

Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis

acute extra renal replacement therapy

Intervention Type: PROCEDURE

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

Interventions

acute extra renal replacement therapy

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

Intervention Type: PROCEDURE

Other Intervention Names

Non applicable.

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theophile Gaillot, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Pediatric intensive care - Centre mère enfants

Sainte-Foy, , Canada

Pediatric intensive care -

Sherbrooke, , Canada

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

Vandœuvre-lès-Nancy, , France

Groupe hospitalier Sud Reunion

Réunion, , Reunion

Countries

Canada; France; Reunion

Other Identifiers

2010-A00670-39

Identifier Type: -

Identifier Source: org_study_id