Long-term Mortality in Diabetics Undergoing Major Surgery

• ClinicalTrials.gov Identifier: NCT00286572
• Recruitment Status: Completed
• First Posted: February 3, 2006
• Last Update Posted: March 10, 2015
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): Daniel Bolliger, University Hospital, Basel, Switzerland

Study Description

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.

Condition or disease
Diabetes Mellitus; Coronary Heart Disease; Major Non-cardiac Surgery

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 Design

• Study Type: Observational
• Actual Enrollment: 380 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: January 2004
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2010

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Death and/or major adverse cardiac events [ Time Frame: 12 months after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with treated diabetes mellitus undergoing surgery with major risk or patients with treated diabetes mellitus and known coronary artery disease undergoing surgery with major or intermediate risk

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

Contacts and Locations

Locations

Switzerland

University Hospital

Basel, CH, Switzerland, 4000

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Miodrag Filipovic, PD Dr.; University Hospital, Basel, Switzerland

More Information

• Responsible Party: Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT00286572
• Other Study ID Numbers: 129/03
• First Posted: February 3, 2006
• Last Update Posted: March 10, 2015
• Last Verified: March 2015

Keywords provided by Daniel Bolliger, University Hospital, Basel, Switzerland:

insulin-dependent diabetes mellitus; non-insulin-dependent diabetes mellitus; coronary artery disease; long-term mortality

Additional relevant MeSH terms:

Coronary Artery Disease; Heart Diseases; Coronary Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases