EUCTR2014-000980-42-AT
Active, not recruiting
Not Applicable
Feasibility and safety of intensified preoperative glucose control in patients with type 2 diabetes undergoing cardiovascular surgery – a pilotstudy - Diabetes and cardiothoracic surgery
Medical University Vienna0 sites40 target enrollmentSeptember 2, 2014
ConditionsThe 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]
DrugsNovo Rapid
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- Medical University Vienna
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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