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

NCT ID: NCT04948593

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-03

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Native kidney biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patient with a transplanted kidney
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Simeone Andrulli, MD

OTHER

Sponsor Role lead

Responsible Party

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Simeone Andrulli, MD

Simeone Andrulli, MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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San Giovanni di Dio Hospital

Agrigento, , Italy

Site Status

Giovanni XXIII pediatric Hospital

Bari, , Italy

Site Status

Policlinico Hospital

Bari, , Italy

Site Status

S. Orsola Hospital

Bologna, , Italy

Site Status

Cannizzaro Hospital

Catania, , Italy

Site Status

S. Camillo Hospital

Chieti, , Italy

Site Status

Santa Croce Hospital

Cuneo, , Italy

Site Status

Maria SS. Addolorata Hospital

Eboli, , Italy

Site Status

University Hospital

Foggia, , Italy

Site Status

Policlinico Hospital

Messina, , Italy

Site Status

Cervello Hospital

Palermo, , Italy

Site Status

Riuniti Hospital

Parma, , Italy

Site Status

Ospedali Riuniti Marche Nord Hospital

Pesaro, , Italy

Site Status

Cisanello Hospital

Pisa, , Italy

Site Status

Umberto 1° Hospital

Roma, , Italy

Site Status

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

Sollievo Sofferenza Hospital

San Giovanni Rotondo, , Italy

Site Status

Belcolle Hospital

Viterbo, , Italy

Site Status

Countries

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Italy

Related Links

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http://www.irrb.net/

Italian Registry Renal Biopsy

Other Identifiers

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KidneyBiopsyRisk in Italy

Identifier Type: -

Identifier Source: org_study_id

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