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

NCT02960867 | Completed

• 1 other identifier: 1041_OPBG_2016
• Study Type: observational
• Target: 1,892
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

paediatric; kidney

Outcome Measures

Primary Outcomes (1)

• incidence of AKI requiring dialysis in PICU and non-PICU children

  urine output and serum creatinine

  3 years

Secondary Outcomes (8)

• Mortality rates

  3 years

• difference in mortality related to dialysis modality

  3 years

• difference in the primary outcome related to duration of mechanical ventilation

  3 years

• difference in the primary outcome related to severity score

  3 years

• difference in the primary outcome related to SpO2

  3 years

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mariella Enoc: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

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

Rome, Italy

Location

Related Publications (10)

• 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. doi: 10.1097/CCM.0b013e3181cd12e1.

  PMID: 20124891 RESULT

• Bailey D, Phan V, Litalien C, Ducruet T, Merouani 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. doi: 10.1097/01.pcc.0000256612.40265.67.

  PMID: 17251879 RESULT

• Medina Villanueva A, Lopez-Herce Cid J, Lopez Fernandez Y, Anton Gamero M, Concha Torre A, Rey Galan C, Santos Rodriguez F. [Acute renal failure in critically-ill children. A preliminary study]. An Pediatr (Barc). 2004 Dec;61(6):509-14. doi: 10.1016/s1695-4033(04)78437-4. Spanish.

  PMID: 15574251 RESULT

• 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. doi: 10.1038/sj.ki.5002231. Epub 2007 Mar 28.

  PMID: 17396113 RESULT

• 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: 10.1038/ki.2013.349. Epub 2013 Sep 18.

  PMID: 24048379 RESULT

• 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.

  PMID: 18434915 RESULT

• 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 Injury Study Group. Etiology and outcome of acute kidney injury in children. Pediatr Nephrol. 2010 Aug;25(8):1453-61. doi: 10.1007/s00467-010-1541-y. Epub 2010 May 30.

  PMID: 20512652 RESULT

• 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 critically ill children: a two-center retrospective cohort study. Crit Care. 2011 Jun 10;15(3):R146. doi: 10.1186/cc10269.

  PMID: 21663616 RESULT

• 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.

  PMID: 23519522 RESULT

• Guzzo I, de Galasso L, Bayazit AK, Yildizdas D, Schmitt CP, Hayes W, Shroff R, Jankauskiene A, Virsilas E, Longo G, Vidal E, Mir S, Bulut IK, Tkaczyk M, Mencarelli F, Bertulli C, Cvetkovic M, Kostic M, Paglialonga F, Montini G, Yilmaz E, Teixeira A, Atmis B, Schaefer F. Acute paediatric kidney replacement therapies in Europe: demographic results from the EurAKId Registry. Nephrol Dial Transplant. 2022 Mar 25;37(4):770-780. doi: 10.1093/ndt/gfab280.

  PMID: 34586417 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stefano Picca

  Bambino Gesù Children's Hospital

  STUDY CHAIR

• Isabella Guzzo

  Bambino Gesù Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 10, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)