Role of desmopressin in renal biopsy in patients with renal dysfunction (CKD-EPI with GFR < 45ml/min)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Major bleed requiring blood transfusion
研究概览
简要总结
- Renal biopsy is associated with bleeding complications like post biopsy hematoma, macroscopic hematuria, etc.
- Currently, percutaneous renal biopsy (PRB) is being used, with the aid of ultrasound (US) and spring-loaded biopsy needle in order to decrease the associated complications.
- Desmopressin, a synthetic analogue of the ADH hormone, is known to improve functioning of platelets and decrease bleeding occurring because of uremia.
- Desmopressin provides a clinical benefit to biopsy patients at risk of complication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •eGFR less than 45 ml per minute.
排除标准
- •Pregnancy Post renal transplant patient Uncontrolled hypertension Haemoglobin< 8 gm/dl Platelet count < 85,000/μL Active bleeding Evidence of active urinary tract infection Diagnosis of a congenital abnormality of kidneys or urinary tract.
结局指标
主要结局
Major bleed requiring blood transfusion
时间窗: Hb estimation at 6-8 hours | USG at 6-8 hours
Major bleed requiring intervention
时间窗: Hb estimation at 6-8 hours | USG at 6-8 hours
Major bleed requiring nephrectomy
时间窗: Hb estimation at 6-8 hours | USG at 6-8 hours
Major bleed leading to mortality
时间窗: Hb estimation at 6-8 hours | USG at 6-8 hours
次要结局
- Haematuria(Haematoma 5 cm)