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NCT04948593 Clinical Trial

The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study

Kidney Diseases Clinical Trial

Official title:
The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04948593
Other study ID # KidneyBiopsyRisk in Italy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2012
Est. completion date May 31, 2021

Study information
Verified date June 2021
Source A. Manzoni Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. So far no prospective multicentre studies has been designed to identify rates of biopsy related complications. The aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in Italy.

Description:

Kidney biopsies performed in 54 italian nephrology centres from 2012 to 2020 were included. Primary outcome of the study was any major complication, such as haemoglobin decrease more than 2 g/dL, macroematuria, gross ematoma, blood transfusion, artero-venous fistula, invasive intervention, pain, symptomatic hypotension, and/or rapid serum creatinine increase. Centre and individual patient risk predictors were analysed using multivariate logistic regression analysis.

Recruitment information / eligibility
Status Completed
Enrollment 5304
Est. completion date May 31, 2021
Est. primary completion date August 4, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - adult or pediatric patients with a kidney disease - informed Consent Exclusion Criteria: - patient with a transplanted kidney

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Native kidney biopsy

Locations
Country Name City State
Italy San Giovanni di Dio Hospital Agrigento
Italy Giovanni XXIII pediatric Hospital Bari
Italy Policlinico Hospital Bari
Italy S. Orsola Hospital Bologna
Italy Cannizzaro Hospital Catania
Italy S. Camillo Hospital Chieti
Italy Santa Croce Hospital Cuneo
Italy Maria SS. Addolorata Hospital Eboli
Italy University Hospital Foggia
Italy Policlinico Hospital Messina
Italy Cervello Hospital Palermo
Italy Riuniti Hospital Parma
Italy Ospedali Riuniti Marche Nord Hospital Pesaro
Italy Cisanello Hospital Pisa
Italy Umberto 1° Hospital Roma
Italy Istituto Clinico Humanitas Rozzano
Italy Sollievo Sofferenza Hospital San Giovanni Rotondo
Italy Belcolle Hospital Viterbo

Sponsors (1)
Lead Sponsor Collaborator
Simeone Andrulli, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Any major post-biopsy complication event The cecked of major post-biopsy complication events were clinically relevant hematomas, macrohematuria, decrease of haemoglobin levels after 24 hours > 2 g /dL, the need for blood transfusion, a large and persistent AV fistula, a post-biopsy anuria, an increase in serum creatinine greater than 50% in the week following biopsy, the need for invasive post-biopsy procedure related to the procedure including nephrectomy, the death related to biopsy one week follow-up after native kidney biopsy
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