Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 7:24 AM
Study NCT ID:
NCT04948593
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study
Sponsor:
Simeone Andrulli, MD
Organization:
Study Overview
Official Title:
The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: