Dept. Anaesthesiology, Mater University Hospital, University College Dublin, Dublin, Ireland
Mater University Hospital, University College Dublin, Dublin, Ireland.
BMJ Open. 2021 Sep 6;11(9):e044394. doi: 10.1136/bmjopen-2020-044394.
Diabetes is common (about 20 million patients in Europe) and patients with diabetes have more surgical interventions than the general population. There are plausible pathophysiological and clinical mechanisms suggesting that patients with diabetes are at an increased risk of postoperative complications. When postoperative complications occur in the general population, they increase major adverse events and subsequently increase 1-year mortality. This is likely to be worse in patients with diabetes. There is variation in practice guidelines in different countries in the perioperative management of patients with diabetes undergoing major surgery and whether this may affect postoperative outcome has not been investigated on a large scale. Neither is it known whether different strata of preoperative glycaemic control affects outcome.
A prospective, observational, international, multicentre cohort study, recruiting 5000 patients with diabetes undergoing elective or emergency surgery in at least n=50 centres. Inclusion criteria are any patient with diabetes undergoing surgery under any substantive anaesthetic technique. Exclusion criteria are not being a confirmed diabetic patient and patients with diabetes undergoing procedures under monitored sedation or local anaesthetic infiltration only. Follow-up duration is 30 days after surgery. Primary outcome is days at home at 30 days. Secondary outcomes are Comprehensive Complications Index, Quality of Recovery (QoR-15) score on Day 1 postoperatively, 30-day mortality, length of hospital stay and incidence of specific major adverse events (Myocardial Infarction (MI), Myocardial Injury after Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI), Postoperative Pulmonary Complications (PPC), Cerebrovascular Accident (CVA), Pulmonary Embolism (PE), DVT, surgical site infection, postoperative pulmonary infection). Tertiary outcomes include time to resumption of normal diabetes therapy, incidence of diabetic ketoacidosis or hypoglycaemia, incidence and duration of use of intravenous insulin infusion therapy and change in diabetic management at 30 days.
This study will adhere to the principles of the Declaration of Helsinki (amendment 2013) by the World Medical Association and the ICH-Good Clinical Practice (GCP) Guidelines E6(R2). Specific national and local regulatory authority requirements will be followed as applicable. Ethical approval has been granted by the Institutional Review Board of the Mater Misericordiae University Hospital, Dublin, Ireland (Reference: 1/378/2167). As enrolment for this study is ongoing, ethical approval from additional centres is being added continuously. The main results of Management and Outcomes of Perioperative Care among European Diabetic Patients and its substudies will be published in peer-reviewed international medical journals and presented at Euroanaesthesia congress and other international and national meetings.
NCT04511312.
糖尿病很常见（欧洲约有 2000 万患者），且糖尿病患者的手术干预比一般人群更多。有合理的病理生理学和临床机制表明，糖尿病患者术后并发症的风险增加。当一般人群发生术后并发症时，会增加主要不良事件，随后增加 1 年死亡率。对于糖尿病患者来说，情况可能更糟。不同国家的围手术期管理指南存在差异，并且尚未在大规模研究中调查这是否会影响术后结果。也不知道不同术前血糖控制水平是否会影响结果。
这是一项前瞻性、观察性、国际性、多中心队列研究，将在至少 50 个中心招募 5000 名接受择期或急诊手术的糖尿病患者。纳入标准为任何接受任何实质性麻醉技术的糖尿病患者。排除标准为不是确诊的糖尿病患者和仅接受监测镇静或局部麻醉浸润的糖尿病患者。随访时间为术后 30 天。主要结局为术后 30 天在家的天数。次要结局为术后第 1 天的综合并发症指数（Comprehensive Complication Index）、恢复质量（Quality of Recovery）评分（QoR-15）、30 天死亡率、住院时间和特定主要不良事件（心肌梗死（Myocardial Infarction）、非心脏手术后心肌损伤（Myocardial Injury after Non-cardiac Surgery）、急性肾损伤（Acute Kidney Injury）、术后肺部并发症（Postoperative Pulmonary Complications）、脑血管意外（Cerebrovascular Accident）、肺栓塞（Pulmonary Embolism）、深静脉血栓形成（Deep Vein Thrombosis）、手术部位感染、术后肺部感染）的发生率。三级结局包括恢复正常糖尿病治疗的时间、糖尿病酮症酸中毒或低血糖的发生率、静脉内胰岛素输注治疗的使用时间和 30 天时糖尿病管理的变化。
本研究将遵循世界医学协会（World Medical Association）的《赫尔辛基宣言》（2013 年修订版）和 ICH-GCP 指南（E6(R2)）的原则。将遵循特定的国家和地方监管机构的要求。都柏林 Mater Misericordiae 大学医院机构审查委员会已批准该研究（参考号：1/378/2167）。由于本研究正在进行招募，正在不断增加对其他中心的伦理批准。管理和围手术期护理在欧洲糖尿病患者中的结果及其子研究的主要结果将发表在同行评议的国际医学期刊上，并在 Euroanaesthesia 大会和其他国际和国家会议上进行报告。
NCT04511312。
