E11
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a) People with type 2 diabetes either on dietary control or on glucose lowering treatment including any oral glucose lowering drugs or GLP1-receptor agonists b) Admitted to hospital for cardiac surgery (coronary artery bypass surgery or valve replacement) c) Age 50-80 years (both inclusive) d) Written informed consent
Exclusion criteria
Exclusion criteria: a) Type 1 diabetes b) Pre-existing insulin treatment c) Insulin pump treatment d) Glucocorticoid treatment e) End stage renal disease f) Severe liver impairment g) Any mental condition rendering the patient incapable of giving informed consent h) Participation in another trial which might interfere with the procedures of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of postsurgical complications (including surgical site infection, pneumonia, ICU readmission, acute renal failure, re-hospitalisations). Endpoint definition: Surgical Site infection: an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery. Acute kidney injury: (according to KDIGO, Kidney Int 2012) AKI is defined as any of the following: 1) Increase in sCr =0.3 mg/dL within 48 hours 2) Increase in sCr =1.5 times baseline (visit 1) 3) Urine volume =38.5°C 2) blood leucocyte count >10.000/µL or < 4.000/µL 3) purulent secretion 4) confirmed bacterial or viral infection 5) signs of pneumonia after physical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Composite of postsurgical complications during the index hospital stay only b) Incidence Surgical site infections (CDC definition) c) Length of hospital stay d) Length of ICU stay e) 180-day mortality f) Acute kidney injuries g) Number of re-hospitalisations after discharge h) Hospitalisations for cardiovascular causes (including myocardial infarction, stroke, hospitalisation for heart failure, hospitalisation for revascularisation procedure) i) Number of fatal events j) Glycaemic parameters including TIR, TTR, TARI, TBR1, TAR2, TBR, mean glucose and glucose variability | — |
Countries
Austria
Contacts
Medizinische Universität Graz / Abteilung für Endokrinologie und Diabetologie