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

April 13, 2021 updated by: Rennes University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Sainte-Foy, Canada, G1V 4G2
        • Pediatric intensive care - Centre mère enfants
      • Sherbrooke, Canada, J1H 5N4
        • Pediatric intensive care -
  • France
      • Angers, France
        • Angers University Hospital
      • Besançon, France
        • Besançon University Hospital
      • Bordeaux, France, 33076
        • Pediatry - Bordeaux University Hospital
      • Brest, France, 29609
        • Reanimation pediatric - Morvan Hospital
      • Caen, France, 14000
        • Pediatry - Cote De Nacre University Hospital
      • Grenoble, France, 38043
        • Pediatric nephrology - Hôpital Couple-enfants
      • Le Kremlin Bicêtre, France
        • Bicetre University Hospital
      • Limoges, France, 87000
        • Pediatry - Hopital de la Mère et de l'Enfant
      • Marseille, France, 13920
        • Anesthesy-Pediatric reanimation - Nord University Hospital
      • Montpellier, France
        • Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital
      • Nantes, France, 44093
        • Pediatric reanimation - Hôpital mère-enfant
      • Paris, France, 75007
        • Réanimation et Surveillance - Robert Debre Hospital
      • Reims, France, 51092
        • Pediatry - Reims University Hospital
      • Toulouse, France, 31059
        • Nephrology - Hôpital des enfants
      • Tours, France, 37044
        • Nephrology - Pediatric emergency - Clocheville University Hospital
      • Vandoeuvre Les Nancy, France, 54511
        • Pediatric reanimation - Brabois Hospital
  • Réunion
      • Reunion, Réunion
        • Groupe Hospitalier Sud Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with an acute renal failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
extrarenal replacement therapy
Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis
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 Names:
  • Non applicable.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at day 60 +/- 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Current incidence
Time Frame: at day 60 +/- 7
Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure
at day 60 +/- 7
etiologies
Time Frame: at day 0
Acute kidney injury etiologies leading to extra renal replacement therapy
at day 0
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
at day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Theophile Gaillot, MD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010-A00670-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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