Long-term Mortality in Diabetics Undergoing Major Surgery

Completed

• Conditions: Coronary Heart Disease; Diabetes Mellitus; Major Non-cardiac Surgery

• Registration Number: NCT00286572
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.

Detailed Description

Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity.

In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery.

The "normal" perioperative treatment of the study is not changed by the study itself.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-02-02
• Study First Submitted QC: 2006-02-02
• Study First Posted: 2006-02-03
• Primary Completion: 2009-08
• Study Completion: 2010-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• diabetes mellitus with insulin or oral antidiabetics
• proven coronary artery disease or very high risk for it
• major non-vascular surgery

Exclusion Criteria

• emergency
• no consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death and/or major adverse cardiac events	12 months after surgery

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, CH, Switzerland