Hulst Abraham H, Visscher Maarten J, Godfried Marc B, Thiel Bram, Gerritse Bas M, Scohy Thierry V, Bouwman R Arthur, Willemsen Mark G A, Hollmann Markus W, DeVries J Hans, Preckel Benedikt, Hermanides Jeroen
Department of Anaesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Department of Anaesthesiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
BMJ Open. 2018 Jun 4;8(6):e022189. doi: 10.1136/bmjopen-2018-022189.
Perioperative hyperglycaemia is common during cardiac surgery and associated with postoperative complications. Although intensive insulin therapy for glycaemic control can reduce complications, it carries the risk of hypoglycaemia. GLP-1 therapy has the potential to lower glucose without causing hypoglycaemia. We hypothesise that preoperative liraglutide (a synthetic GLP-1 analogue) will reduce the number of patients requiring insulin to achieve glucose values<8 mmol l in the intraoperative period.
We designed a multi-centre randomised parallel placebo-controlled trial and aim to include 274 patients undergoing cardiac surgery, aged 18-80 years, with or without diabetes mellitus. Patients will receive 0.6 mg liraglutide or placebo on the evening before, and 1.2 mg liraglutide or placebo just prior to surgery. Blood glucose is measured hourly and controlled with an insulin bolus algorithm, with a glycaemic target between 4-8 mmol l. The primary outcome is the percentage of patients requiring insulin intraoperatively.
This study protocol has been approved by the medical ethics committee of the Academic Medical Centre (AMC) in Amsterdam and by the Dutch competent authority. The study is investigator-initiated and the AMC, as sponsor, will remain owner of all data and have all publication rights. Results will be submitted for publication in a peer-reviewed international medical journal.
NTR6323; Pre-results.
围手术期高血糖在心脏手术期间很常见，且与术后并发症相关。尽管强化胰岛素治疗以控制血糖可减少并发症，但存在低血糖风险。胰高血糖素样肽-1（GLP-1）疗法有可能降低血糖而不引起低血糖。我们假设术前使用利拉鲁肽（一种合成的GLP-1类似物）将减少术中需要胰岛素以将血糖值控制在<8 mmol/L的患者数量。
我们设计了一项多中心随机平行安慰剂对照试验，目标纳入274例年龄在18至80岁之间、无论是否患有糖尿病的接受心脏手术的患者。患者将在术前一晚接受0.6 mg利拉鲁肽或安慰剂，并在手术即将开始前接受1.2 mg利拉鲁肽或安慰剂。每小时测量血糖，并采用胰岛素推注算法进行控制，血糖目标为4至8 mmol/L。主要结局是术中需要胰岛素的患者百分比。
本研究方案已获得阿姆斯特丹学术医疗中心（AMC）医学伦理委员会和荷兰主管当局的批准。该研究由研究者发起，作为主办方的AMC将保留所有数据的所有权并拥有所有发表权。研究结果将提交至同行评审的国际医学期刊发表。
NTR6323；预结果。
