A Double-blind Randomised Placebo-controlled Feasibility Study to Assess the Impact of Octreotide Infusion During Liver Transplantation on Post-operative Renal Failure.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ability to recruit patients.
研究概览
简要总结
The purpose of the study is to determine whether an octreotide infusion during liver transplantation improves renal outcomes, intraoperative blood pressure and reduces haemorrhage and transfusion requirement.
详细描述
Common and serious complications of liver transplantation surgery include renal failure, haemorrhage and blood transfusion. These complications prolong post-operative recovery, increase the risk of liver graft failure, mortality and the need for long-term renal dialysis.
The drug octreotide is a synthetic analogue of somatostatin with comparable physiological effects and a good side-effect profile. Existing evidence in liver transplantation supports octreotide efficacy in improving renal function, reducing bleeding and enhancing blood pressure. However, there is no robust randomised controlled trial evidence for octreotide in liver transplantation and limited safety data regarding its use in this setting.
This is a multi centre, prospective double-blind, randomised, placebo-controlled trial of octreotide infusion during liver transplantation. The patients will be randomised in a 2:1 ratio to either octreotide or placebo groups. Stratified randomisation of patients is by donation type (DCD vs. DBD).
Patients will be randomised in the anaesthetic room and study medication given as an initial bolus of 5ml (100mcg octreotide or saline) prior to surgical incision and then continued throughout surgery at 5ml/hr (100mcg/hour octreotide or saline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding (masking) will be achieved through the use of identical active drug product and control study drug syringes that are allocated by centrally-controlled and administered randomisation such that no clinical, research or statistical support staff are aware of allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and over undergoing primary liver transplantation of a whole or partial liver graft from a cardiac or brain dead donor.
- •Provision of written informed consent.
排除标准
- •Previous solid organ transplant.
- •Acute liver failure.
- •Fulminant hepatic failure.
- •Patients receiving a living donor liver graft.
- •Patients currently admitted to ICU prior to transplantation.
- •Requirement of haemodialysis or CVVHF pre-operatively.
- •Known allergy or adverse reaction to octreotide.
- •Pre-operative decision to use intra-operative CVVHF.
- •A positive pregnancy test.
研究组 & 干预措施
Intervention group
Octreotide intravenous infusion, 100mcg bolus with a subsequent infusion of 100mcg per hour during surgery.
干预措施: Octreotide Acetate (Drug)
Placebo group
Sodium chloride 0.9% w/v
干预措施: Placebo (Other)
结局指标
主要结局
Ability to recruit patients.
时间窗: Approximately 180 days.
This will be assessed by: • Ability to recruit patients (target: ≥ 30% consent rate of eligible patients admitted for transplant)
Completion of the study intervention.
时间窗: Approximately 9.5 hours.
This will be assessed by: • The percentage of patients successfully completing the study intervention. Defined as eligible patients who receive the entire study drug infusion in a blinded manner.
次要结局
- The incidence of acute kidney injury.(Within 24, 72 and 168 hours post-operatively.)
- Incidence of new chronic kidney disease or deterioration of chronic kidney disease.(At thirty and ninety days post operative.)
- Incidence of early allograft dysfunction.(At day seven post-operatively)
- Patient mortality.(At thirty and ninety days post-operatively.)
- Intra-operative red blood cell salvage.(Within 24, 72 and 168 hours post-operatively.)
- Volume of packed red blood cell transfusion.(Intra-operatively and at 24, 72 and 168 hours post-operatively.)
- Incidence of adverse events secondary to study drug infusion.(Intra-operatively and up to 24 hours post-operatively.)
- PROMs_ data collection_1(For EuroQoL-5D-5, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months.)
- PROMs_ data collection_2(For LDQOL, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months.)
- Post-operative incidence of a new requirement for renal replacement therapy.(Within 24 hours, 72 hours, one and two weeks post-operatively.)