Trials / Completed
CompletedNCT04948593
The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study
The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,304 (actual)
- Sponsor
- Simeone Andrulli, MD · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Native kidney biopsy |
Timeline
- Start date
- 2012-01-03
- Primary completion
- 2020-08-04
- Completion
- 2021-05-31
- First posted
- 2021-07-02
- Last updated
- 2021-07-02
Locations
18 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04948593. Inclusion in this directory is not an endorsement.