Long-term Mortality in Diabetics Undergoing Major Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Daniel Bolliger, University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT00286572

First received: February 2, 2006

Last updated: March 9, 2015

Last verified: March 2015

History of Changes

Purpose

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
Diabetes Mellitus Coronary Heart Disease Major Non-cardiac Surgery


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Death and/or major adverse cardiac events [ Time Frame: 12 months after surgery ] [ Designated as safety issue: Yes ]


Enrollment:	380
Study Start Date:	January 2004
Study Completion Date:	August 2010
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286572

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 History of Changes
Other Study ID Numbers:	129/03
Study First Received:	February 2, 2006
Last Updated:	March 9, 2015
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 28, 2016

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