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

Acute Kidney Injury Clinical Trial

— EurAKID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960867
• Other study ID #: 1041_OPBG_2016
• Status: Completed
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1892
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Italy	Department of Nephrology-Urology "Bambino Gesù" Children's Research Hospital	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Mariella Enoc	Baxter Healthcare Corporation

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Akcan-Arikan A, Zappitelli M, Loftis LL, Washburn KK, Jefferson LS, Goldstein SL. Modified RIFLE criteria in critically ill children with acute kidney injury. Kidney Int. 2007 May;71(10):1028-35. Epub 2007 Mar 28. — View Citation

Alabbas A, Campbell A, Skippen P, Human D, Matsell D, Mammen C. Epidemiology of cardiac surgery-associated acute kidney injury in neonates: a retrospective study. Pediatr Nephrol. 2013 Jul;28(7):1127-34. doi: 10.1007/s00467-013-2454-3. Epub 2013 Mar 22. — View Citation

Alkandari O, Eddington KA, Hyder A, Gauvin F, Ducruet T, Gottesman R, Phan V, Zappitelli M. Acute kidney injury is an independent risk factor for pediatric intensive care unit mortality, longer length of stay and prolonged mechanical ventilation in critic — View Citation

Bailey D, Phan V, Litalien C, Ducruet T, Mérouani A, Lacroix J, Gauvin F. Risk factors of acute renal failure in critically ill children: A prospective descriptive epidemiological study. Pediatr Crit Care Med. 2007 Jan;8(1):29-35. — View Citation

Barrantes F, Tian J, Vazquez R, Amoateng-Adjepong Y, Manthous CA. Acute kidney injury criteria predict outcomes of critically ill patients. Crit Care Med. 2008 May;36(5):1397-403. doi: 10.1097/CCM.0b013e318168fbe0. — View Citation

Basu RK, Zappitelli M, Brunner L, Wang Y, Wong HR, Chawla LS, Wheeler DS, Goldstein SL. Derivation and validation of the renal angina index to improve the prediction of acute kidney injury in critically ill children. Kidney Int. 2014 Mar;85(3):659-67. doi — View Citation

Duzova A, Bakkaloglu A, Kalyoncu M, Poyrazoglu H, Delibas A, Ozkaya O, Peru H, Alpay H, Soylemezoglu O, Gur-Guven A, Bak M, Bircan Z, Cengiz N, Akil I, Ozcakar B, Uncu N, Karabay-Bayazit A, Sonmez F; Turkish Society for Pediatric Nephrology Acute Kidney I — View Citation

Medina Villanueva A, López-Herce Cid J, López Fernández Y, Antón Gamero M, Concha Torre A, Rey Galán C, Santos Rodríguez F. [Acute renal failure in critically-ill children. A preliminary study]. An Pediatr (Barc). 2004 Dec;61(6):509-14. Spanish. — View Citation

Schneider J, Khemani R, Grushkin C, Bart R. Serum creatinine as stratified in the RIFLE score for acute kidney injury is associated with mortality and length of stay for children in the pediatric intensive care unit. Crit Care Med. 2010 Mar;38(3):933-9. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of AKI requiring dialysis in PICU and non-PICU children	urine output and serum creatinine	3 years
Secondary	Mortality rates	mortality	3 years
Secondary	difference in mortality related to dialysis modality	CRRT modality (CVVH, CVVHD, CVVHDF)	3 years
Secondary	difference in the primary outcome related to duration of mechanical ventilation	duration of mechanical ventilation	3 years
Secondary	difference in the primary outcome related to severity score	severity score	3 years
Secondary	difference in the primary outcome related to SpO2	SpO2	3 years
Secondary	difference in the primary outcome related to FiO2	FiO2	3 years
Secondary	difference in the primary outcome related to Mean Airway Pressure	Mean Airway Pressure	3 years
Secondary	difference in the primary outcome related to paO2	paO2	3 years