Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

NCT01569698 | Terminated

• 1 other identifier: 2010-A00670-39
• Study Type: observational
• Target: 310
• Locations: 3 countries
• Sites: 19

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.

Conditions

Kidney Failure, Acute

Keywords

pediatric; acute renal failure; acute extra renal replacement therapy; Intermittent Hemodialysis; Continuous Renal Replacement Therapies; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Current incidence

  at day 60 +/- 7

• etiologies

  at day 0

• Risk factors of mortality and non recovery of the renal function

  at day 60

Study Arms (1)

extrarenal replacement therapy

Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis

Procedure: acute extra renal replacement therapy

Interventions

acute extra renal replacement therapy PROCEDURE

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

Also known as: Non applicable.

extrarenal replacement therapy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with an acute renal failure

You may qualify if:

• Age \< 18 years, including the newborn ;
• Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (19)

Pediatric intensive care - Centre mère enfants

Sainte-Foy, G1V 4G2, Canada

Location

Pediatric intensive care -

Sherbrooke, J1H 5N4, Canada

Location

Angers University Hospital

Angers, France

Location

Besançon University Hospital

Besançon, France

Location

Pediatry - Bordeaux University Hospital

Bordeaux, 33076, France

Location

Reanimation pediatric - Morvan Hospital

Brest, 29609, France

Location

Pediatry - Cote De Nacre University Hospital

Caen, 14000, France

Location

Pediatric nephrology - Hôpital Couple-enfants

Grenoble, 38043, France

Location

Bicêtre University Hospital

Le Kremlin-Bicêtre, France

Location

Pediatry - Hopital de la Mère et de l'Enfant

Limoges, 87000, France

Location

Anesthesy-Pediatric reanimation - Nord University Hospital

Marseille, 13920, France

Location

Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital

Montpellier, France

Location

Pediatric reanimation - Hôpital mère-enfant

Nantes, 44093, France

Location

Réanimation et Surveillance - Robert Debre Hospital

Paris, 75007, France

Location

Pediatry - Reims University Hospital

Reims, 51092, France

Location

Nephrology - Hôpital des enfants

Toulouse, 31059, France

Location

Nephrology - Pediatric emergency - Clocheville University Hospital

Tours, 37044, France

Location

Pediatric reanimation - Brabois Hospital

Vandœuvre-lès-Nancy, 54511, France

Location

Groupe hospitalier Sud Reunion

Réunion, Reunion

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Theophile Gaillot, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: April 3, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: July 1, 2019
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

FR (16); CA (2); RE (1)