BACKGROUND Perioperative hyperglycemia is associated with poor outcomes yet evidence to guide intraoperative goals and treatment modalities during non-cardiac surgery are lacking. End-stage liver disease is associated with altered glucose homeostasis; patients undergoing liver transplantation display huge fluctuations in blood glucose (BG) and represent a population of great interest. Here, we conduct a randomized trial to compare the effects of strict versus conventional glycemic control during orthotopic liver transplant (OLT). METHODS Following approval by the Institutional Review Board of the University of Michigan Medical School and informed consent, 100 adult patients undergoing OLT were recruited. Patients were randomized to either strict (target BG 80-120 mg/dL) or conventional (target BG 180-200 mg/dL) BG control with block randomization for diabetic and nondiabetic patients. The primary outcomes measured were 1-year patient and graft survival assessed on an intention to treat basis. Graft survival is defined as death or needing re-transplant (www.unos.org). Three and 5-year patient and graft survival, infectious and biliary complications were measured as secondary outcomes. Data were examined using univariate methods and Kaplan-Meir survival analysis. A sensitivity analysis was performed to compare patients with a mean BG of ≤120 mg/dL and those > 120 mg/dL regardless of treatment group. RESULTS There was no statistically significant difference in patient survival between conventional and strict control respectively;1 year, 88% vs 88% (p-0.99), 3 years, 86% vs 84% (p- 0.77), 5 years, 82% vs 78. % (p-0.36). Graft survival was not different between conventional and strict control groups at 1 year, 88% vs 84% (p-0.56), 3 years 82% vs 76% (p-0.46), 5 years 78% vs 70% (p-0.362). CONCLUSION There was no difference in patient or graft survival between intraoperative strict and conventional glycemic control during OLT. TRIAL REGISTRATION Clinical trial number and registry: www.clinicaltrials.gov NCT00780026. This trial was retrospectively registered on 10/22/2008.

中文翻译：

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进行原位肝移植患者的术中血糖控制：一项单中心前瞻性随机研究。

背景技术围手术期高血糖与不良预后相关，但缺乏在非心脏手术期间指导术中目标和治疗方式的证据。终末期肝病与葡萄糖稳态的改变有关。接受肝移植的患者显示出血糖（BG）的巨大波动，代表了人们的极大兴趣。在这里，我们进行了一项随机试验，比较了原位肝移植（OLT）期间严格和常规血糖控制的效果。方法经密歇根大学医学院的机构审查委员会批准并获得知情同意后，招募了100名接受OLT的成年患者。患者随机分为严格（目标BG 80-120 mg / dL）或常规（目标BG 180-200 mg / dL）BG对照，对糖尿病和非糖尿病患者采用区组随机分组。测得的主要结局为1年患者，并根据治疗意图评估了移植物存活率。移植物存活定义为死亡或需要重新移植（www.unos.org）。将次要结果评估为3年和5年患者和移植物存活，感染和胆道并发症。使用单变量方法和Kaplan-Meir生存分析检查数据。进行敏感性分析以比较平均BG≤120 mg / dL和大于120 mg / dL的患者，与治疗组无关。结果：常规控制和严格控制之间的患者存活率无统计学差异； 1年，88％vs 88％（p-0.99），3年，86％vs 84％（p-0.77），5年，82％vs 78.％（p-0.36）。常规和严格对照组之间的移植存活率在1年时无差异，分别为88％vs 84％（p-0.56），3年82％vs 76％（p-0.46），5年78％vs 70％（p-0.362） ）。结论OLT期间术中严格和常规血糖控制在患者或移植物存活率方面无差异。试验注册临床试验编号和注册：www.clinicaltrials.gov NCT00780026。该试验已于2008年10月22日进行回顾性注册。结论OLT期间术中严格和常规血糖控制在患者或移植物存活率方面无差异。试验注册临床试验编号和注册：www.clinicaltrials.gov NCT00780026。该试验已于2008年10月22日进行回顾性注册。结论OLT期间术中严格和常规血糖控制在患者或移植物存活率方面无差异。试验注册临床试验编号和注册：www.clinicaltrials.gov NCT00780026。该试验已于2008年10月22日进行回顾性注册。