NCT04511312

Management and Outcomes of Perioperative Care Among European Diabetic Patients

Recruiting now Last updated 17 April 2024

What this trial tests

trial in Diabetes Mellitus in 5,000 participants. Currently enrolling.

Timeline

1 May 2021

Primary endpoint
30 April 2024

31 August 2024

Quick facts

Lead sponsor	European Society of Anaesthesiology
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	1 May 2021
Primary completion	30 April 2024
Estimated completion	31 August 2024
Sites	1 location across Ireland

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Postoperative Complications — all drugs for Postoperative Complications →

Sponsor

European Society of Anaesthesiology

Who can join

18 and older, any sex, with Diabetes Mellitus or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocol for a prospective, international cohort study on the Management and Outcomes of Perioperative Care among European Diabetic Patients (MOPED).
   Buggy DJ, Nolan R, Coburn M, Columb M, et al · · 2021 · cited 9× · PMID 34489264 · DOI 10.1136/bmjopen-2020-044394
2. Management and Outcomes of Perioperative Care of People with Diabetes across Europe (MOPED): a prospective, observational study.
   Buggy DJ, Columb MO, Hermanides J, Hollmann MW, et al · · 2026 · cited 3× · PMID 41362298 · DOI 10.1016/j.lanepe.2025.101535
3. Perioperative Management of Patients with Diabetes and Cancer: Challenges and Opportunities.
   Shouman M, Brabant M, Rehman N, Ahmed S, et al · · 2024 · cited 3× · PMID 39199594 · DOI 10.3390/cancers16162821