Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial
This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. One group will receive Tab UDCA starting atleast 10 days pre-operatively and continued till post-operative day 10 and the other group will receive placebo. UDCA will be given at a dose of 15mg/kg per day in two divided doses. Recipients who are not willing to participate in the study, have hypersensitivity to UDCA will be excluded from the study. Pediatrics recipients and acute liver failure recipients will also be excluded.
Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system (PACS). The enrolled subjects will be followed up till for a period of 14 days after the transplant till NCCT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers (HGF, TNF-Alpha, IL6, TGF-Beta1) will be compared between the two groups. Evaluation of incidence of Early Allograft Dysfunction (EAD) as per Modified Olthoff criteria1 will be done between the two groups. FXR receptor concentration (hepatocytes) and TGR-5 receptor concentration (cholangiocytes) will be seen in the explant liver along with evaluation of monocyte number and function and mitochondrial and nuclear DNA.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Rajguru Siwach, MS
- 电话号码:01146300000
- 邮箱:rajgurusiwach@gmail.com
研究联系人备份
- 姓名:Dr Nihar Mohapatra, MCh
- 电话号码:01146300000
- 邮箱:nihar0310@gmail.com
学习地点
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National Capital Territory of Delhi
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New Delhi、National Capital Territory of Delhi、印度、110070
- ILBS
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接触:
- Rajguru Siwach, MS
- 电话号码:01146300000
- 邮箱:rajgurusiwach@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
All Adult Living Donor Liver Transplant (LDLT) Recipients in ILBS from ethical board clearance to December 2027 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences
Exclusion Criteria:
- Unwillingness to participate
- Hypersensitivity to UDCA
- Patients receiving UDCA pre-operatively within 1 month of liver transplant (PBC and patients of overlap syndrome)
- Right posterior and left laterals grafts
- Emergency Liver Transplant
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Ursodeoxycholic acid+standard medical treatment
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标准医疗
Tab Ursodeoxycholic acid 15mg/kg in two divided doses
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有源比较器:Placebo+standard medical treatment
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标准医疗
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Regenerated liver volume
大体时间:Post-Operative Day 14
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Post-Operative Day 14
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Regeneration Liver Indices • Percentage restoration of SLV (Standard liver volume) • Regeneration index (%) : (Regenerated liver volume-GW/GW)x100 • Kinetic growth rate (volume in CC/Day)
大体时间:Post-Operative Day 14
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Regeneration Liver Indices is defined by-
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Post-Operative Day 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Liver Function test
大体时间:Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Change in Coagulation parameter
大体时间:Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Change in Serum levels of biomarkers.
大体时间:Post-Operative Day 0, 2, 5 and 7
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Post-Operative Day 0, 2, 5 and 7
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Daily ascitic fluid output in drain/24hr
大体时间:Daily till Post-Operative Day 14
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Daily till Post-Operative Day 14
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Total ascitic fluid output till POD-14
大体时间:Post-Operative Day 14
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Post-Operative Day 14
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Bile acid receptors expression for UDCA.
大体时间:Post-Operative Day 1
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{FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver}
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Post-Operative Day 1
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Evaluation of monocyte number and function (flowcytometry)
大体时间:Post-Operative Day 1
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Post-Operative Day 1
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Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry
大体时间:Post-Operative Day 14
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Post-Operative Day 14
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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