NCT04184401已完成4 期
Effect of Albumin Administration Strategy for Ascites Replacement on Time to 1st Flatus After Liver Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to 1st diet
研究概览
简要总结
The aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (19 years or older)
- •Elective living donor liver transplantation
排除标准
- •Previous abdominal surgery
- •Renal failure requiring renal replacement therapy
- •Contraindications for 5% albumin use
- •Condition with potential risk caused by increased circulating plasma (heart failure, renal failure combined with oliguria, pulmonary edema)
- •Hemolytic anemia
- •Contraindications for Hartmann solution
- •Progressive lactic acidosis
- •Hypervolemia
- •Hypernatremia
研究组 & 干预措施
Replacement with albumin
Experimental
- Check drain amount every 4 hour after SICU admission
- Replacement of 70% of drainage from previous 4 hours over next 4 hours
- 30% of the drainage with 5% albumin
- 40% of drainage with Hartmann's solution
- If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution
- If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin
干预措施: Ascites replacement with albumin and hartmann's solution (Drug)
Replacement with Hartmann's solution
Active Comparator
- Check drain amount every 4 hour after SICU admission
- Replacement of 70% of drainage from previous 4 hours with Hartmann's solution over next 4 hours
- If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution
- If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin
干预措施: Ascites replacement with hartmann's solution (Drug)
结局指标
主要结局
Time to 1st diet
时间窗: within 4 weeks
Interval between SICU admission and 1st diet
Time to 1st flatus
时间窗: within 4 weeks
Interval between SICU admission and 1st flatus
次要结局
未报告次要终点
研究者
Ho Geol Ryu
Associate Professor
Seoul National University Hospital
研究点 (1)
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