Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Post operative complications
研究概览
简要总结
In this study, we aim to analyse the effect of phosphate supplementation on donors undergoing partial hepatectomy for LDLT. In Group A, we are going to supplement phosphate in donors postoperatively from day 1 to day 5. We will analyse the trend of serum phosphate levels in donors postoperatively, its correlation with occurrence of postoperative complications and status of liver regeneration by CT volumetry on Day 7. Group B will constitute the controls for the study and hence attempt to find out the effect of phosphate supplementation in all donors postoperatively. We will analyse the data and elucidate the value of phosphate supplementation in reducing the occurrence of complications and effect on liver regeneration in donors in LDLT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All donors evaluated as per institutional protocol for donor hepatectomy and found fit
- •Those who consent.
排除标准
- •Patients refusing to consent for inclusion in the study.
- •Minor hepatectomy
- •Those who develop profound hypophosphatemia in the control group
研究组 & 干预措施
Intervention Arm - potassium phosphate injection
干预措施: Potassium Phosphate Injection (Drug)
结局指标
主要结局
Post operative complications
时间窗: 1 month
Outcome of phosphate supplementation in reducing the occurrence of postoperative complications assessed by Clavien Dindo grading
次要结局
- Trend of serum phosphorous levels(1 week)
- Duration of hospital, ICU stay(Till patient is discharged on an average of 10 days)
- Trends in post-operative liver function tests(1 week)
研究者
Vivek Rajendran
Senior Resident, Department of HPB surgery and liver transplantation
Institute of Liver and Biliary Sciences, India