Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury (EPURE)

• ClinicalTrials.gov Identifier: NCT01569698
• Recruitment Status: Terminated
• First Posted: April 3, 2012
• Last Update Posted: April 15, 2021
• Sponsor: Rennes University Hospital
• Information provided by (Responsible Party): Rennes University Hospital

Tracking Information

• First Submitted Date: March 23, 2012
• First Posted Date: April 3, 2012
• Last Update Posted Date: April 15, 2021
• Study Start Date: June 2012
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2014)

extra renal replacement therapy [ Time Frame: 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.

Original Primary Outcome Measures (submitted: March 30, 2012)

extra renal replacement therapy [ Time Frame: at day 60 +/- 3 ]

To describe usual modalities of pediatric acute extra renal replacement therapy including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis.

Current Secondary Outcome Measures (submitted: June 4, 2014)

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

Original Secondary Outcome Measures (submitted: March 30, 2012)

• Current incidence [ Time Frame: at day 60 +/- 3 ]
  Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure
• etiologies [ Time Frame: at day 0 ]
  Acute kidney injury etiologies leading to extra renal replacement therapy
• Risk factors of mortality and non recovery of the renal function [ Time Frame: 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
• Official Title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Children with an acute renal failure
• Condition: Kidney Failure, Acute

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

Other Name: Non applicable.

Study Groups/Cohorts

extrarenal replacement therapy

Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis

Intervention: Procedure: acute extra renal replacement therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 10, 2018): 310
• Original Estimated Enrollment (submitted: March 30, 2012): 600
• Actual Study Completion Date: July 2019
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Réunion

Administrative Information

• NCT Number: NCT01569698
• Other Study ID Numbers: 2010-A00670-39
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rennes University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Rennes University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Theophile Gaillot, MD; Rennes University Hospital

• PRS Account: Rennes University Hospital
• Verification Date: April 2021