Long-term Mortality in Diabetics Undergoing Major Surgery

NCT ID: NCT00286572

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Diabetes Mellitus; Coronary Heart Disease; Major Non-cardiac Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Daniel Bolliger

PD Dr. Daniel Bolliger

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miodrag Filipovic, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital

Basel, CH, Switzerland

Countries

Switzerland

Other Identifiers

129/03

Identifier Type: -

Identifier Source: org_study_id