Kidney Failure, AcuteEPURENCT01569698
Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
An observational study of Kidney Failure, Acute, run by Rennes University Hospital at 19 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Kidney Failure, Acute
- What is being tested?
- acute extra renal replacement therapy
- Type of treatment
- Surgery or procedure
- How many people
- 310 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Jun 2012to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with an acute renal failure
Who may be able to join
- Age < 18 years, including the newborn ;
- Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
France16 sites
Angers University Hospital
Angers
Besançon University Hospital
Besançon
Pediatry - Bordeaux University Hospital
Bordeaux, 33076
Reanimation pediatric - Morvan Hospital
Brest, 29609
Pediatry - Cote De Nacre University Hospital
Caen, 14000
Pediatric nephrology - Hôpital Couple-enfants
Grenoble, 38043
Bicêtre University Hospital
Le Kremlin-Bicêtre
Pediatry - Hopital de la Mère et de l'Enfant
Limoges, 87000
Anesthesy-Pediatric reanimation - Nord University Hospital
Marseille, 13920
Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital
Montpellier
Pediatric reanimation - Hôpital mère-enfant
Nantes, 44093
Réanimation et Surveillance - Robert Debre Hospital
Paris, 75007
Pediatry - Reims University Hospital
Reims, 51092
Nephrology - Hôpital des enfants
Toulouse, 31059
Nephrology - Pediatric emergency - Clocheville University Hospital
Tours, 37044
Pediatric reanimation - Brabois Hospital
Vandœuvre-lès-Nancy, 54511
Canada2 sites
Pediatric intensive care - Centre mère enfants
Sainte-Foy, G1V 4G2
Pediatric intensive care -
Sherbrooke, J1H 5N4
About this study
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.
Read the 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
- Being tested
- acute extra renal replacement therapy
- Keywords
- pediatric, acute renal failure, acute extra renal replacement therapy, Intermittent Hemodialysis, Continuous Renal Replacement Therapies, Peritoneal Dialysis
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute extra renal replacement therapyProcedure or surgery
Also called Non applicable.
usual modalities of pediatric acute extra renal replacement therapy : Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis
| Study group | Role | What they receive |
|---|---|---|
| extrarenal replacement therapy | Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis Receives: Procedure: acute extra renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 60 +/- 7
Secondary outcomes (3)
Current incidence
Current incidence of the use of extra renal replacement therapy in pediatric acute renal failure
Measured: at day 60 +/- 7
etiologies
Acute kidney injury etiologies leading to extra renal replacement therapy
Measured: at day 0
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
Measured: at day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2016
- Study completionJul 2019
Why it stopped: sponsor and investigator's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theophile Gaillot, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569698
- Sponsor's protocol ID
- 2010-A00670-39
- Acronym
- EPURE
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2012
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01569698
- Acronym / sponsor ID
- EPURE / 2010-A00670-39
- Conditions
- Kidney Failure, Acute
- Keywords
- pediatric, acute renal failure, acute extra renal replacement therapy, Intermittent Hemodialysis, Continuous Renal Replacement Therapies, Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sponsor and investigator's decision
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extrarenal replacement therapy | – | Procedure: acute extra renal replacement therapyIntermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with an acute renal failure
Key inclusion criteria (2 listed)
- Age < 18 years, including the newborn ;
- Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute extra renal replacement therapyAlso: Non applicable.usual modalities of pediatric acute extra renal replacement therapy : Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis | Procedure or surgery | extrarenal replacement therapy |
Primary outcome
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.
3 secondary outcomes
Current incidence
Time frame: at day 60 +/- 7
etiologies
Time frame: at day 0
Risk factors of mortality and non recovery of the renal function
Time frame: at day 60
Results and safety
The study was stopped early (reason given: sponsor and investigator's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theophile Gaillot, MD principal investigator
Rennes University Hospital
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Acute, run by Rennes University Hospital at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Canada, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sponsor and investigator's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extra renal replacement therapy (time frame: at day 60 +/- 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.