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Controlling Glucose during Elective hip Surgery To study the influence on Coagulation.


- candidate number13180
- NTR NumberNTR3547
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2012
- Secondary IDsNL38327.018.11 / U1111-1122-8888; CCMO / UTN
- Public TitleControlling Glucose during Elective hip Surgery To study the influence on Coagulation.
- Scientific TitleControlling Glucose during Elective hip Surgery To study the influence on Coagulation.
- ACRONYMCONGEST trial
- hypothesisTo investigate the efficacy of liraglutide to lower glucose and to influence coagulation activation during and after hip surgery.
- Healt Condition(s) or Problem(s) studiedLiraglutide, Hip surgery, Peri-operative glycemic control
- Inclusion criteria1. Signed informed consent;
2. Planned for elective hip replacement surgery;
3. Age 18-75 years inclusive;
4. Fraxiparine or Dabigatran used as anticoagulant drug.
- Exclusion criteria1. 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 Ámol/L for males and > 115 Ámol/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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-aug-2012
- planned closingdate1-jul-2013
- Target number of participants36
- Interventions1. 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.
- Primary outcomeThe difference in mean glucose between the CG and the LG at day 3 after surgery.
- Secondary outcomeThe difference in mean glucose between CG and the LG during surgery, the between group difference in mean coagulation parameters, the between group difference in mean glucagon and cortisol 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.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.K. Sechterberger
- CONTACT for SCIENTIFIC QUERIES M.K. Sechterberger
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Novo Nordisk
- PublicationsN/A
- Brief summaryStudy carried out in the Netherlands.
- Main changes (audit trail)
- RECORD30-jul-2012 - 11-dec-2013


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