A04 K83.0
Conditions
Interventions
Group 1: Preoperative administration (2h continuously) of Ceftazidime/Avibactam and perioperative measurement of antibiotic concentration in blood and bile
Sponsors
Universitätsklinikum Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerzmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Male or female patients / 18 to 64 years of age / Patient requiring cholecystectomy because of cholecystitis or cholecystolithiasis or other elective abdominal surgery
Exclusion criteria
Exclusion criteria: Treatment with investigational drug within 28 days prior to start of study medication / Contra-indication for a perioperative antibiotic prophylaxis according to the standard in-house regimen (e.g. cholecystectomy with perforation of gallbladder) / Any medication considered relevant for proper performance of the study at the discretion of the investigator / Sepsis / Severe hepatitis or severe hepatic dysfunction / Renal impairment with need of renal replacement therapy / Pregnancy or lactation / Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator. Explicitly an icterus, cholestasis, cholangitis, cholecytitis, hepatitis, congested liver, allergies, Clostridioides-difficile infection, relevant concomitant medication (e.g. metformin, ursodeoxycholic acid, statins) must be considered / No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bile CAZ/AVI concentrations at 2h±1h (n=4), 4h±1h (n=4), and 8h±1h (n=4) after continuous intravenous infusion over 2 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma CAZ/AVI concentrations at baseline and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7,h and 8h after CAZ/AVI infusion. Key pharmacokinetic parameters of CAZ/AVI in plasma and bile fluid. | — |
Countries
Germany
Contacts
Public ContactTim Rahmel
Universitätsklinikum Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Outcome results
None listed