Role of Perioperative Pentoxifylline on Liver Regeneration in Living Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- the liver regeneration at POD 8 which will measured by non-contrast three-dimensional computed tomography/magnetic resonance imaging
研究概览
简要总结
After written informed consent, a pilot study will be conducted with 10 patients to assess for feasibility and drug safety following which the double-blinded randomized control trial (DB- RCT) will be carried out. For the DB- RCT, the patients will be randomized using computer generated randomization charts in to two groups: the Pentox group (Group I) and the Placebo group (Group C). The randomization and drug delivery will be done by independent personnel (Third party - not related to the study). The patients in the Pentox arm will receive Oral pentoxifylline 24 hours before LDLT at doses upto 15mg/kg in three divided doses and then continued till 7 days postoperatively. The control group will receive color-matched multivitamin tablets as placebo. Monitoring for drug related adverse events described according to the product monograph will be closely carried out. These include: cardiovascular system: Arrhythmias, unexplained tachycardia; Central nervous system: Dizziness, headache, somnolence; Gastrointestinal symptoms: Nausea, vomiting, heartburn, constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •all Living donor liver transplant recipients with an expected graft recipient weight ratio less than 0.8.
排除标准
- •Unwilling for participation, acute liver failure and acute on chronic liver failure, MELD score more than 30, chronic kidney disease, cardiac dysfunction such as arrhythmia, heart blocks and coronary artery disease.
结局指标
主要结局
the liver regeneration at POD 8 which will measured by non-contrast three-dimensional computed tomography/magnetic resonance imaging
时间窗: till 8 th postoperative day
次要结局
- 1. Assessment of the incidence of small for size syndrome(2. Assessment of degree of postoperative liver injury by daily measurement of postoperative serum transaminases, bilirubin and prothrombin time (PT)/international normalized ratio (INR) until POD 7)
研究者
Susan Paulin
Dr Rela Institute And Medical Centre
