Peninsula Medical School, University of Plymouth, Plymouth, Devon, UK
Department of Anaesthesia, Royal Free London NHS Foundation Trust, London, UK.
BMJ Open. 2021 Dec 2;11(12):e055864. doi: 10.1136/bmjopen-2021-055864.
Liver transplantation is a complex operation that can provide significant improvements in quality of life and survival to the recipients. However, serious complications are common and include major haemorrhage, hypotension and renal failure. Blood transfusion and the development of acute kidney injury lead to both short-term and long-term poor patient outcomes, including an increased risk of death, graft failure, length of stay and reduced quality of life. Octreotide may reduce the incidence of renal dysfunction, perioperative haemorrhage and enhance intraoperative blood pressure. However, octreotide does have risks, including resistant bradycardia, hyperglycaemia and hypoglycaemia and QT prolongation. Hence, a randomised controlled trial of octreotide during liver transplantation is needed to determine the cost-efficacy and safety of its use; this study represents a feasibility study prior to this trial.
We describe a multicentre, double-blind, randomised, placebo-controlled feasibility study of continuous infusion of octreotide during liver transplantation surgery. We will recruit 30 adult patients at two liver transplant centres. A blinded infusion during surgery will be administered in a 2:1 ratio of octreotide:placebo. The primary outcomes will determine the feasibility of this study design. These include the recruitment ratio, correct administration of blinded study intervention, adverse event rates, patient and clinician enrolment refusal and completion of data collection. Secondary outcome measures of efficacy and safety will help shape future trials by assessing potential primary outcome measures and monitoring safety end points. No formal statistical tests are planned. This manuscript represents study protocol number 1.3, dated 2 June 2021.
This study has received Research Ethics Committee approval. The main study outcomes will be submitted to an open-access journal.
The Joint Research Office, University College London, UK.Neither the sponsor nor the funder have any role in study design, collection, management, analysis and interpretation of data, writing of the study report or the decision to submit the report for publication.
The study is registered with ClinicalTrials.gov (NCT04941911) with recruitment due to start in August 2021 with anticipated completion in July 2022.
Surgical and Interventional Group, Division of Surgery & Interventional Science, University College London.
肝移植是一项复杂的手术，可以显著提高受者的生活质量和生存率。然而，严重并发症很常见，包括大出血、低血压和肾衰竭。输血和急性肾损伤的发展导致短期和长期预后不良，包括死亡风险增加、移植物衰竭、住院时间延长和生活质量降低。奥曲肽可降低肾功能障碍、围手术期出血的发生率，并增强术中血压。然而，奥曲肽确实存在风险，包括心动过缓、高血糖和低血糖以及 QT 延长。因此，需要进行奥曲肽在肝移植中的随机对照试验，以确定其使用的成本效益和安全性；本研究代表该试验之前的可行性研究。
我们描述了一项多中心、双盲、随机、安慰剂对照的奥曲肽在肝移植手术中连续输注的可行性研究。我们将在两家肝移植中心招募 30 名成年患者。术中给予奥曲肽与安慰剂以 2:1 的比例进行盲法输注。主要结局将确定本研究设计的可行性。这些包括招募比例、正确给予盲法研究干预、不良事件发生率、患者和临床医生的入组拒绝率以及数据收集的完成情况。疗效和安全性的次要结局指标将通过评估潜在的主要结局指标和监测安全性终点来帮助确定未来的试验。未计划进行正式的统计检验。本文代表 2021 年 6 月 2 日的研究方案 1.3。
本研究已获得伦理委员会批准。主要研究结果将提交给开放获取期刊。
英国伦敦大学学院联合研究办公室。赞助商和资助者在研究设计、数据的收集、管理、分析和解释、研究报告的撰写以及提交报告进行发表的决定方面均无任何作用。
该研究在 ClinicalTrials.gov 上注册（NCT04941911），预计于 2021 年 8 月开始招募，预计于 2022 年 7 月完成。
外科和介入组，外科和介入科学系，伦敦大学学院。
