hip surgery hyperglycemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Signed informed consent -Planned for elective hip replacement surgery at the AMC -Age 18-75 years inclusive -Fraxiparine used as anticoagulant drug
Exclusion criteria
Exclusion criteria: - Known type 1 or type 2 diabetes mellitus - Oral corticosteroid use - Use of a Vitamin K antagonist (VKA) as anticoagulant drug - Revision hip replacement - Known coagulation disorders - Peripheral nerve block peri-operative - Known active cancer of the subject - History of chronic pancreatitis or idiopathic acute pancreatitis - Impaired liver function, defined as alanine aminotransferase (ALAT) * 2.5 times upper normal limit - Impaired renal function defined as serum-creatinine * 133 µmol/L for males and * 115 µmol/L for females - Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) - Known or suspected allergy to trial product(s) or related products - Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter will be the difference in mean glucose between both groups at day 3 after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study outcomes will be mean differences in coagulation parameters (PAI-1, PAP, F1+2, FVIII, TAT, ETP, PT, APTT, vWF, D-Dimer and antithrombin levels), cortisol and glucagon levels and the difference in proportion of patients who have glucose values in fasting state below 7.8 mmol/l at day 3 after surgery. | — |
Countries
Netherlands