Prophylactic Desmopressin and Bleeding Outcomes After Native Kidney Biopsy in Patients With Severe Renal Impairment: A Prospective Sequential Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Overall bleeding complications after native kidney biopsy
研究概览
简要总结
This study evaluated whether giving desmopressin before a native kidney biopsy reduces bleeding complications in adults with severe renal impairment (eGFR <30 mL/min/1.73 m²). Patients undergoing kidney biopsy were enrolled sequentially into two groups: a non-desmopressin group and a desmopressin group. Patients were monitored for 24 hours after biopsy for bleeding complications, including perinephric hematoma, a decrease in hemoglobin, blood in the urine, need for blood transfusion, and other complications. The study also evaluated whether desmopressin was associated with adverse effects such as low blood sodium levels.
详细描述
This prospective sequential cohort study evaluated the association between prophylactic intranasal desmopressin use and bleeding complications following native kidney biopsy in adults with severe renal impairment. The study was conducted at the Sindh Institute of Urology and Transplantation (SIUT), Karachi, from October 2024 to September 2025. Adults aged 18 years or older with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² who underwent native kidney biopsy for clinical indications were consecutively enrolled. Patients were sequentially enrolled into a non-desmopressin cohort from October 2024 to March 2025 and a desmopressin cohort from April 2025 to September 2025. All patients underwent ultrasound-guided kidney biopsy and were monitored clinically and by ultrasonography for 24 hours after the procedure. The study evaluated post-biopsy bleeding complications and safety outcomes, including perinephric hematoma, hemoglobin decline, gross hematuria, blood transfusion, invasive interventions, and changes in serum sodium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older who provided informed consent, had an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², and underwent native kidney biopsy for a clinical indication, irrespective of dialysis status.
排除标准
- •Pregnant women, kidney transplant recipients, and patients with contraindications to kidney biopsy.
研究组 & 干预措施
Non-Desmopressin Group
Patients undergoing native kidney biopsy who did not receive prophylactic desmopressin. Patients were monitored for 24 hours after biopsy for bleeding complications and other safety outcomes.
干预措施: NO DESMOPRESSIN (Other)
Desmopressin Group
Patients undergoing native kidney biopsy who received prophylactic intranasal desmopressin before the biopsy. Patients were monitored for 24 hours after biopsy for bleeding complications and other safety outcomes.
干预措施: Desmopressin Acetate (Drug)
结局指标
主要结局
Overall bleeding complications after native kidney biopsy
时间窗: Within 24 hours after kidney biopsy
Occurrence of any post-biopsy bleeding complication, including clinically relevant perinephric hematoma, hemoglobin decline ≥2 g/dL, persistent or clinically significant gross hematuria, or other clinically significant bleeding complications.
次要结局
- Perinephric hematoma >5 cm, Hemoglobin decline ≥2 g/dL, Blood transfusion requirement, Hyponatremia(Within 24 hours after kidney biopsy)
研究者
Siddiq Kakar
SIDDIQ KAKAR
Sindh Institute of Urology and Transplantation