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

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT02960867
• Lead Sponsor: Mariella Enoc

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Primary Completion: 2019-03
• Study Completion: 2019-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1892

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of AKI requiring dialysis in PICU and non-PICU children	3 years	urine output and serum creatinine

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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