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

June 24, 2021 updated by: Simeone Andrulli, MD

The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data collection of native kidney biopsies was centralized and takes place via Web by means of an ad hoc web-database linked to the National Italian Renal Biopsy Registry (http://www.irrb.net/). As this is an observational study, we collect information already available and typical of usual clinical practice. There are no particular requested exams.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patient with a transplanted kidney

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one week follow-up after native kidney biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simeone Andrulli, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2012

Primary Completion (Actual)

August 4, 2020

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KidneyBiopsyRisk in Italy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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