Rare and ultra-rare glomerulonephritis
Conditions
Brief summary
Efficacy primary outcome: Number of major and minor bleeding events in 24 h after the procedure which is defined as: • minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. • Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death., Safety primary outcome: Hyponatremia 24 and 48 h after biopsy
Detailed description
Efficacy secondary outcome: Hospitalization time from kidney biopsy till discharge, Efficacy secondary outcome: Cost-effectiveness analysis of desmopressin use, Safety secondary outcome Frequency of AEs of special interest: • Tachycardia HR>100 BPM • Hypotension defined as SBP <90 mmHg or MAP <65 mgHg or a systolic blood pressure decrease of 40 mmHg. • Any thrombotic events
Interventions
Sponsors
Medical University Of Bialystok
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy primary outcome: Number of major and minor bleeding events in 24 h after the procedure which is defined as: • minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. • Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death., Safety primary outcome: Hyponatremia 24 and 48 h after biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy secondary outcome: Hospitalization time from kidney biopsy till discharge, Efficacy secondary outcome: Cost-effectiveness analysis of desmopressin use, Safety secondary outcome Frequency of AEs of special interest: • Tachycardia HR>100 BPM • Hypotension defined as SBP <90 mmHg or MAP <65 mgHg or a systolic blood pressure decrease of 40 mmHg. • Any thrombotic events | — |
Countries
Poland
Outcome results
None listed