European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI) (EurAKID)

May 21, 2019 updated by: Mariella Enoc

Acute kidney injury (AKI) is a frequent clinical condition in hospitalized, in particular, in critically ill children. Moreover, AKI is an independent predictor of mortality. An incidence of AKI in pediatric intensive care units (PICU) between 10 and 62% has been reported in recent clinical trials adopting pRIFLE or AKIN criteria, with the highest risk present in cardiac surgery patients. Despite significant developments in the management of AKI, the overall mortality rate of patients with AKI has not improved significantly. Currently, there is no consensus concerning the optimum dialysis modalities to adopt in pediatric AKI. No studies have prospectively compared the efficacy of different types of RRT for pediatric AKI. While PD remains the most commonly used modality in children worldwide, over the last decade CRRT has become the preferred treatment modality for critically ill children with AKI in North America.

The investigators have recently conducted a survey among 34 European Pediatric Nephrology Centers in the ESCAPE Network to obtain current information on dialysis management practices in children. Approximately 900 children with AKI requiring dialysis are managed at these 34 centers per year. This number supports the creation of a prospective European AKI registry.

Study Overview

Status

Completed

Conditions

Detailed Description

The main scope of the Registry is to report the epidemiology and outcome of children with AKI treated with dialysis in over 30 Pediatric Nephrology Centers in Europe. Secondary aims are to verify the association of a specific dialysis modality with the outcome and the association of primary disease, co-morbidities, nephrotoxic agents, fluid overload, anuria, basic hemodynamic parameters (BP, HR), basic nutritional intakes (protein and calorie supply) with the outcome.

Data capture will be exclusively web-based via electronic case report forms. Every participating site will be provided with a unique code and password that identify the corresponding site.

Study Type

Observational

Enrollment (Actual)

1892

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

  • Italy
      • Rome, Italy
        • Department of Nephrology-Urology "Bambino Gesù" Children's Research Hospital

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

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with AKI admitted to general PICUs and to cardiac ICUs will be included in the Registry.

Description

Inclusion Criteria:

  • Children with AKI at Hospital admission or who developed AKI during hospitalization treated with dialysis (PD, HD, CRRT)
  • Age: 0-18 yrs

Exclusion Criteria:

  • Children with known preexisting CKD (i.e.: AKI on CKD)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of AKI requiring dialysis in PICU and non-PICU children
Time Frame: 3 years
urine output and serum creatinine
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rates
Time Frame: 3 years
mortality
3 years
difference in mortality related to dialysis modality
Time Frame: 3 years
CRRT modality (CVVH, CVVHD, CVVHDF)
3 years
difference in the primary outcome related to duration of mechanical ventilation
Time Frame: 3 years
duration of mechanical ventilation
3 years
difference in the primary outcome related to severity score
Time Frame: 3 years
severity score
3 years
difference in the primary outcome related to SpO2
Time Frame: 3 years
SpO2
3 years
difference in the primary outcome related to FiO2
Time Frame: 3 years
FiO2
3 years
difference in the primary outcome related to Mean Airway Pressure
Time Frame: 3 years
Mean Airway Pressure
3 years
difference in the primary outcome related to paO2
Time Frame: 3 years
paO2
3 years

Collaborators and Investigators

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

Sponsor

Mariella Enoc

Collaborators

Baxter Healthcare Corporation

Investigators

  • Study Chair: Stefano Picca, Bambino Gesù Children's Hospital
  • Principal Investigator: Isabella Guzzo, Bambino Gesù Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1041_OPBG_2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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