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NCT00286572 Clinical Trial

Long-term Mortality in Diabetics Undergoing Major Surgery

Diabetes Mellitus Clinical Trial

Official title:
Comparison in Survival in Patients With Insulin-dependent and Non-insulin-dependent Diabetes Mellitus With Known or Suspected Coronary Artery Disease Undergoing Major Non-cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00286572
Other study ID # 129/03
Secondary ID
Status Completed
Phase N/A
First received February 2, 2006
Last updated March 9, 2015
Start date January 2004
Est. completion date August 2010

Study information
Verified date March 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 380
Est. completion date August 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University Hospital Basel CH

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Death and/or major adverse cardiac events 12 months after surgery Yes
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