Clinical trial NCT04948593: The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study
Official title: The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Diseases
Lead sponsor: A. Manzoni Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 5304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patient with a transplanted kidney

Primary outcomes:
measure: Any major post-biopsy complication event
timeFrame: one week follow-up after native kidney biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Agrigento
country: Italy
facility: San Giovanni di Dio Hospital
city: Bari
country: Italy
facility: Giovanni XXIII pediatric Hospital
city: Bari
country: Italy
facility: Policlinico Hospital
city: Bologna
country: Italy
facility: S. Orsola Hospital
city: Catania
country: Italy
facility: Cannizzaro Hospital
city: Chieti
country: Italy
facility: S. Camillo Hospital
city: Cuneo
country: Italy
facility: Santa Croce Hospital
city: Eboli
country: Italy
facility: Maria SS. Addolorata Hospital
city: Foggia
country: Italy
facility: University Hospital
city: Messina
country: Italy
facility: Policlinico Hospital
city: Palermo
country: Italy
facility: Cervello Hospital
city: Parma
country: Italy
facility: Riuniti Hospital
city: Pesaro
country: Italy
facility: Ospedali Riuniti Marche Nord Hospital
city: Pisa
country: Italy
facility: Cisanello Hospital
city: Roma
country: Italy
facility: Umberto 1° Hospital
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Sollievo Sofferenza Hospital
city: Viterbo
country: Italy
facility: Belcolle Hospital
Study officials:
References: