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Completed

NCT Number: NCT02960867

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology-Urology "Bambino Gesù" Children's Research Hospital

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. incidence of AKI requiring dialysis in PICU and non-PICU children

    Time frame: 3 years

    urine output and serum creatinine

Secondary outcomes

  1. Mortality rates

    Time frame: 3 years

    mortality

  2. difference in mortality related to dialysis modality

    Time frame: 3 years

    CRRT modality (CVVH, CVVHD, CVVHDF)

  3. difference in the primary outcome related to duration of mechanical ventilation

    Time frame: 3 years

    duration of mechanical ventilation

  4. difference in the primary outcome related to severity score

    Time frame: 3 years

    severity score

  5. difference in the primary outcome related to SpO2

    Time frame: 3 years

    SpO2

  6. difference in the primary outcome related to FiO2

    Time frame: 3 years

    FiO2

  7. difference in the primary outcome related to Mean Airway Pressure

    Time frame: 3 years

    Mean Airway Pressure

  8. difference in the primary outcome related to paO2

    Time frame: 3 years

    paO2

Sponsors and collaborators

Lead sponsor

Mariella Enoc

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Acronym: EurAKID

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 10, 2016
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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