Clinical trial NCT02960867: European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)
Official title: European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: paediatric
kidney
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2016-11-10
Enrollment: 1892
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AKI admitted to general PICUs and to cardiac ICUs will be included in the Registry.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: incidence of AKI requiring dialysis in PICU and non-PICU children
timeFrame: 3 years
Secondary outcomes:
measure: Mortality rates
timeFrame: 3 years
measure: difference in mortality related to dialysis modality
timeFrame: 3 years
measure: difference in the primary outcome related to duration of mechanical ventilation
timeFrame: 3 years
measure: difference in the primary outcome related to severity score
timeFrame: 3 years
measure: difference in the primary outcome related to SpO2
timeFrame: 3 years
measure: difference in the primary outcome related to FiO2
timeFrame: 3 years
measure: difference in the primary outcome related to Mean Airway Pressure
timeFrame: 3 years
measure: difference in the primary outcome related to paO2
timeFrame: 3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Nephrology-Urology "Bambino Gesù" Children's Research Hospital
Study officials:
affiliation: Bambino Gesù Children's Hospital
name: Stefano Picca
role: STUDY_CHAIR
affiliation: Bambino Gesù Children's Hospital
name: Isabella Guzzo
role: PRINCIPAL_INVESTIGATOR
References:
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