Feasibility and safety of preoperative glucose control in patients with type 2 diabetes undergoing cardiovascular surgery
- Conditions
- The objective of this study is to investigate whether a targeted preoperative glucose control before planned cardiac surgery by i.v. insulin infusion (intensified glycemic control, ICG) versus standard care improves postoperative outcome in patients with T2DM. In addition to evaluating involved molecular mechanisms, this study should also strengthen the evidence of guidelines regarding perioperative glucose management of patients with T2DM.Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2014-000980-42-AT
- Lead Sponsor
- Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
oAge 18 – 75 years
oType 2 diabetes mellitus with diet alone or oral antidiabetic agents and/or insulin therapy
oplanned severe cardiovascular surgery
osigned informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
omental condition rendering the patient unable to give informed consent
odiagnosis and/or treatment of cancer during the last five years
oimpaired renal function (creatinine ?3.0mg/dl)
odiabetic ketoacidosis
oHbA1c >13%
ocardiothoracic surgery in the previous 12 months
oPregnant or breast-feeding patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method