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

Completed

• Conditions: Kidney Diseases

• Registration Number: NCT04948593
• Lead Sponsor: Simeone Andrulli, MD

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.

Study Timeline

• Study Start: 2012-01-03
• Primary Completion: 2020-08-04
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5304

Inclusion Criteria

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

Exclusion Criteria

• patient with a transplanted kidney

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any major post-biopsy complication event	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

Trial Locations

Locations (17)

S. Camillo Hospital; 🇮🇹 Chieti, Italy

Giovanni XXIII pediatric Hospital; 🇮🇹 Bari, Italy

Cannizzaro Hospital; 🇮🇹 Catania, Italy

San Giovanni di Dio Hospital; 🇮🇹 Agrigento, Italy

Policlinico Hospital; 🇮🇹 Messina, Italy

S. Orsola Hospital; 🇮🇹 Bologna, Italy

Santa Croce Hospital; 🇮🇹 Cuneo, Italy

Maria SS. Addolorata Hospital; 🇮🇹 Eboli, Italy

University Hospital; 🇮🇹 Foggia, Italy

Cervello Hospital; 🇮🇹 Palermo, Italy

Riuniti Hospital; 🇮🇹 Parma, Italy

Ospedali Riuniti Marche Nord Hospital; 🇮🇹 Pesaro, Italy

Cisanello Hospital; 🇮🇹 Pisa, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy

Sollievo Sofferenza Hospital; 🇮🇹 San Giovanni Rotondo, Italy

Belcolle Hospital; 🇮🇹 Viterbo, Italy

Umberto 1° Hospital; 🇮🇹 Roma, Italy