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

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.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

San Giovanni di Dio Hospital, Agrigento, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult or pediatric patients with a kidney disease
informed Consent

Exclusion criteria

patient with a transplanted kidney

Treatment and study plan

Native kidney biopsy

Procedure

Primary outcomes

Any major post-biopsy complication event

Time frame: one week follow-up after native kidney biopsy

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

Sponsors and collaborators

Lead sponsor

Simeone Andrulli, MD

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2021
First posted: Jul 2, 2021
Registry last updated: Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed