The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study
1 other identifier
observational
5,304
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedFirst Submitted
Initial submission to the registry
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedJuly 2, 2021
June 1, 2021
8.6 years
June 7, 2021
June 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Any major post-biopsy complication event
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
Interventions
Eligibility Criteria
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.
You may qualify if:
- adult or pediatric patients with a kidney disease
- informed Consent
You may not qualify if:
- patient with a transplanted kidney
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
San Giovanni di Dio Hospital
Agrigento, Italy
Giovanni XXIII pediatric Hospital
Bari, Italy
Policlinico Hospital
Bari, Italy
S. Orsola Hospital
Bologna, Italy
Cannizzaro Hospital
Catania, Italy
S. Camillo Hospital
Chieti, Italy
Santa Croce Hospital
Cuneo, Italy
Maria SS. Addolorata Hospital
Eboli, Italy
University Hospital
Foggia, Italy
Policlinico Hospital
Messina, Italy
Cervello Hospital
Palermo, Italy
Riuniti Hospital
Parma, Italy
Ospedali Riuniti Marche Nord Hospital
Pesaro, Italy
Cisanello Hospital
Pisa, Italy
Umberto 1° Hospital
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Sollievo Sofferenza Hospital
San Giovanni Rotondo, Italy
Belcolle Hospital
Viterbo, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Simeone Andrulli, MD
Study Record Dates
First Submitted
June 7, 2021
First Posted
July 2, 2021
Study Start
January 3, 2012
Primary Completion
August 4, 2020
Study Completion
May 31, 2021
Last Updated
July 2, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share