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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04948593
Enrollment
5304
Registered
2021-07-02
Start date
2012-01-03
Completion date
2021-05-31
Last updated
2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

Brief 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.

Detailed 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.

Interventions

PROCEDURENative kidney biopsy

Sponsors

Simeone Andrulli, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* adult or pediatric patients with a kidney disease * informed Consent

Exclusion criteria

* patient with a transplanted kidney

Design outcomes

Primary

MeasureTime frameDescription
Any major post-biopsy complication eventone week follow-up after native kidney biopsyThe 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026