跳至主要内容
临床试验/NCT04511312
NCT04511312招募中不适用

Management and Outcomes of Perioperative Care Among European Diabetic Patients: (MOPED): A Prospective Observational, International Cohort Study

European Society of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Days at Home at 30 Days after surgery (DAH-30)

研究概览

简要总结

The incidence of diabetes is increasing globally, including within Europe. There is an estimated 20million diabetic patients in Europe, which is likely to increase, thereby adding to societal demands on European health services. Diabetic patients are more likely to have surgical interventions than the general population. There are plausible pathophysiology and clinical mechanisms that diabetics are at increased risk of postoperative complications. When postoperative complications occur in the general population, they increase mortality or increase risk of major adverse cardiovascular events (Myocardial Infarction, Cerebrovascular Accident, Pulmonary embolism) at 30-days and up to one year later. In addition, diabetes is an independent risk factor for surgical site infections.

There is variation in practice guidelines in different countries in the perioperative management of diabetic patients undergoing major surgery, but this has not been documented on a large scale. Given the multiplicity of guidelines and differing recommendations, it is unsurprising that variability of 'real-world' clinical practice with regard to perioperative management of oral antihyperglycemic medications and insulin therapy has been noted in audits such as the National Confidential Enquiry into Patient Outcome and Death (NCEPOD).

Further, although it is recognised that diabetic patients are at increased risk of postoperative complications, this has not been recently evaluated, especially in light of ongoing developments in perioperative care, such as Enhanced Recovery Programmes. While a quality improvement intervention study has shown that maintaining tight preoperative glycaemic control improves postoperative glycaemic control, it is not known if this reduces postoperative morbidity overall. Further, whether certain anaesthetic techniques may be associated with better or worse outcomes after major non-cardiac surgery is unknown.

详细描述

see brief summary

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic patients (all classes except gestational diabetes) undergoing surgery (defined as requiring any general anaesthesia technique or any specific regional anaesthetic technique or a combination)
  • Ambulatory, elective or emergency surgery and patients who receive postoperative care in intensive care or high dependency units will be included.

排除标准

  • Patients who are not diabetic
  • Patients with gestational diabetes
  • Patients undergoing minor surgery

结局指标

主要结局

Days at Home at 30 Days after surgery (DAH-30)

时间窗: 30 days

Number of days at home in the 30 days post surgery

次要结局

  • Quality of Recovery QoR-15 measuring quality of recovery on Day 1 only(Day 1)
  • Comprehensive Complications Index (CCI) score, based on Clavien-Dindo scale;(Day 30)

研究者

发起方
European Society of Anaesthesiology
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验