A Single-center, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Evaluation of safety and efficacy using Somatostatin.
研究概览
简要总结
This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation. Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to provide written informed consent
- •Cirrhotic patients with established clinically significant portal hypertension (CSPH) defined as an increase in hepatic venous pressure gradient >= 10 mmHg
- •Recipients who are 18-70 years of age receiving a primary liver transplant from a brain dead donor or living donor
- •Whole liver grafts and partial liver grafts can be included
排除标准
- •Patients who are recipients of multiple solid organ transplants, or have previously received an organ or tissue transplant that may not be completely resolved by thrombectomy
- •HIV positive patients
- •Patients with known history of portal thrombosis or diagnosed at the time of transplantation that may not be completely resolved by thrombectomy.
- •Patients included in the preoperative assessment without a CSPH at the time of the first intraoperative measurement of portal pressure
- •Patients with low portal perfusion (=< 90 ml/min*100 g of LV) measured at the time of operation. Portal flows above this limit can be excluded in the eventuality that, after infusion, the portal perfusion falls below this limit
- •Patients with porto-pulmonary hypertension
- •Patients with known cardiac arrhythmias
- •Recipients of cardiac-dead donors
- •Fulminant hepatic failure patients
研究组 & 干预措施
Somatostatin
Patients in this group receive treatment with Somatostatin for 5 days.
干预措施: Administration of Somatostatin (Drug)
Placebo
Patients in this group receive a placebo for 5 days.
干预措施: Administration of placebo (Drug)
结局指标
主要结局
Evaluation of safety and efficacy using Somatostatin.
时间窗: 5 days
To evaluate the safety and efficacy, using Somatostatin as portal vein flow and pressure modulator in liver transplantation in humans. Hepatic and systemic hemodynamic measurements will be recorded prior, during and after the bolus infusion of Somatostatin/Placebo during liver transplantation. Infusion of Somatostatin/Placebo will be continued for 5 days.
次要结局
- To elucidate pathophysiological pathways in non-cirrhotic grafted livers.(35 days)
- To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect)(1 hour after reperfusion and 5 days)
- To evaluate the efficacy of Somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation.(after 35 days)