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

Completed

• Conditions: hip surgery; hyperglycemia; 10018424

• Registration Number: NL-OMON37363
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter will be the difference in mean glucose between both groups<br /><br>at day 3 after surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study outcomes will be mean differences in coagulation parameters<br /><br>(PAI-1, PAP, F1+2, FVIII, TAT, ETP, PT, APTT, vWF, D-Dimer and antithrombin<br /><br>levels), cortisol and glucagon levels and the difference in proportion of<br /><br>patients who have glucose values in fasting state below 7.8 mmol/l at day 3<br /><br>after surgery. </p><br>