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Controlling Glucose during Elective hip Surgery to study the influence on Coagulation

Controlling Glucose during Elective hip Surgery to study the influence on Coagulation - CONGEST trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37363
Enrollment
36
Registered
2011-10-18
Start date
2012-08-07
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip surgery hyperglycemia

Interventions

The participants will be randomized to one of the two treatment groups, the liraglutide group (LG) or the control group (CG). Subjects in the LG will start one day prior to surgery with administrati

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Main study parameter will be the difference in mean glucose between both groups at day 3 after surgery

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)