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Acute Kidney InjuryEurAKIDNCT02960867

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

An observational study of Acute Kidney Injury, run by Mariella Enoc at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Acute Kidney Injury
How many people
1,892 participants
Where
1 siteItaly
Study dates
Apr 2016to Apr 2019
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Rome

Other trials in Italy

About this study

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.

Read the 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.

Keywords
paediatric, kidney
Medical subject headings
Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of AKI requiring dialysis in PICU and non-PICU children

    urine output and serum creatinine

    Measured: 3 years

Secondary outcomes (8)

  1. Mortality rates

    mortality

    Measured: 3 years

  2. difference in mortality related to dialysis modality

    CRRT modality (CVVH, CVVHD, CVVHDF)

    Measured: 3 years

  3. difference in the primary outcome related to duration of mechanical ventilation

    duration of mechanical ventilation

    Measured: 3 years

  4. difference in the primary outcome related to severity score

    severity score

    Measured: 3 years

  5. difference in the primary outcome related to SpO2

    SpO2

    Measured: 3 years

  6. difference in the primary outcome related to FiO2

    FiO2

    Measured: 3 years

  7. difference in the primary outcome related to Mean Airway Pressure

    Mean Airway Pressure

    Measured: 3 years

  8. difference in the primary outcome related to paO2

    paO2

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2019
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,892 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960867
Sponsor's protocol ID
1041_OPBG_2016
Acronym
EurAKID
Status last verified
May 2019
First submitted
4 Nov 2016
Last updated
22 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20124891

  • 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.

    PubMed 17251879

  • 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.

    PubMed 15574251

  • 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.

    PubMed 17396113

  • 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.

    PubMed 24048379

  • 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.

    PubMed 18434915

  • 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.

    PubMed 20512652

  • 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.

    PubMed 21663616

  • 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.

    PubMed 23519522

  • 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.

    PubMed 34586417

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury, run by Mariella Enoc at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of AKI requiring dialysis in PICU and non-PICU children (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02960867, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.

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