To investigate the efficacy of liraglutide to lower glucose and to influence coagulation activation during and after hip surgery.
ID
Bron
Verkorte titel
Aandoening
peri-operative glycemic control; hip surgery; liraglutide
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The difference in mean glucose between the CG and the LG at day 3 after surgery.
Achtergrond van het onderzoek
Study carried out in the Netherlands.
Doel van het onderzoek
To investigate the efficacy of liraglutide to lower glucose and to influence coagulation activation during and after hip surgery.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. Liraglutide 0.6 mg once-daily s.c., intensified to 1.2mg after one day if there is no nausea on the starting dose;
2. Placebo, once-daily, s.c.
Blood samples will be obtained for assessment of glucose, coagulation parameters (PAI-1, PAP, F1+2, FVIII, TAT, ETP, PT, APTT, vWF, D-Dimer and antithrombin levels), glucagon and cortisol levels at three timepoints: before surgery, 2 hours post surgery and at day 3 after surgery.
Publiek
Dpt Internal Medicine F4-2257<br>
POBox 22660
M.K. Sechterberger
Amsterdam 1100 DD
The Netherlands
m.k.sechterberger@amc.uva.nl
Wetenschappelijk
Dpt Internal Medicine F4-2257<br>
POBox 22660
M.K. Sechterberger
Amsterdam 1100 DD
The Netherlands
m.k.sechterberger@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Signed informed consent;
2. Planned for elective hip replacement surgery;
3. Age 18-75 years inclusive;
4. Fraxiparine or Dabigatran used as anticoagulant drug.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known type 1 or type 2 diabetes mellitus;
2. Oral corticosteroid use;
3. Use of a Vitamin K antagonist (VKA) as anticoagulant drug;
4. Revision hip replacement;
5. Known coagulation disorders;
6. Peripheral nerve block peri-operative;
7. Known active cancer of the subject;
8. History of chronic pancreatitis or idiopathic acute pancreatitis;
9. Impaired liver function, defined as alanine aminotransferase (ALAT) >2.5 times upper normal limit;
10. Impaired renal function defined as serum-creatinine > 133 µmol/L for males and > 115 µmol/L for females;
11. 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);
12. Known or suspected allergy to trial product(s) or related products;
13. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3404 |
| NTR-old | NTR3547 |
| CCMO | NL38327.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37363 |