Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT02960867
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1892}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of AKI requiring dialysis in PICU and non-PICU children', 'timeFrame': '3 years', 'description': 'urine output and serum creatinine'}], 'secondaryOutcomes': [{'measure': 'Mortality rates', 'timeFrame': '3 years', 'description': 'mortality'}, {'measure': 'difference in mortality related to dialysis modality', 'timeFrame': '3 years', 'description': 'CRRT modality (CVVH, CVVHD, CVVHDF)'}, {'measure': 'difference in the primary outcome related to duration of mechanical ventilation', 'timeFrame': '3 years', 'description': 'duration of mechanical ventilation'}, {'measure': 'difference in the primary outcome related to severity score', 'timeFrame': '3 years', 'description': 'severity score'}, {'measure': 'difference in the primary outcome related to SpO2', 'timeFrame': '3 years', 'description': 'SpO2'}, {'measure': 'difference in the primary outcome related to FiO2', 'timeFrame': '3 years', 'description': 'FiO2'}, {'measure': 'difference in the primary outcome related to Mean Airway Pressure', 'timeFrame': '3 years', 'description': 'Mean Airway Pressure'}, {'measure': 'difference in the primary outcome related to paO2', 'timeFrame': '3 years', 'description': 'paO2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['paediatric', 'kidney'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '20124891', 'type': 'RESULT', '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. doi: 10.1097/CCM.0b013e3181cd12e1.'}, {'pmid': '17251879', 'type': 'RESULT', 'citation': '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': '15574251', 'type': 'RESULT', 'citation': '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': '17396113', 'type': 'RESULT', 'citation': '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': '24048379', 'type': 'RESULT', '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: 10.1038/ki.2013.349. Epub 2013 Sep 18.'}, {'pmid': '18434915', 'type': 'RESULT', '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.'}, {'pmid': '20512652', 'type': 'RESULT', '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 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': '21663616', 'type': 'RESULT', '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 critically ill children: a two-center retrospective cohort study. Crit Care. 2011 Jun 10;15(3):R146. doi: 10.1186/cc10269.'}, {'pmid': '23519522', 'type': 'RESULT', '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.'}, {'pmid': '34586417', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AKI admitted to general PICUs and to cardiac ICUs will be included in the Registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with AKI at Hospital admission or who developed AKI during hospitalization treated with dialysis (PD, HD, CRRT)\n* Age: 0-18 yrs\n\nExclusion Criteria:\n\n* Children with known preexisting CKD (i.e.: AKI on CKD)'}, 'identificationModule': {'nctId': 'NCT02960867', 'acronym': 'EurAKID', 'briefTitle': 'European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)', 'organization': {'class': 'OTHER', 'fullName': 'Bambino Gesù Hospital and Research Institute'}, 'officialTitle': 'European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)', 'orgStudyIdInfo': {'id': '1041_OPBG_2016'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'country': 'Italy', 'facility': 'Department of Nephrology-Urology "Bambino Gesù" Children\'s Research Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Stefano Picca', 'role': 'STUDY_CHAIR', 'affiliation': "Bambino Gesù Children's Hospital"}, {'name': 'Isabella Guzzo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bambino Gesù Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mariella Enoc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mariella Enoc', 'investigatorAffiliation': 'Bambino Gesù Hospital and Research Institute'}}}}