Obesity
Conditions
Keywords
obesity, pharmacokinetic, ertapenem, meropenem
Brief summary
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
Detailed description
The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.
Interventions
PROCEDUREmicrodialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
Sponsors
University of Ulm
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs * BMI more or even 40 * written informed consent
Exclusion criteria
* BMI \< 40 * pregnancy or lactation in women * emergency surgery * history of serious allergy or intolerance to β-lactam antibiotics * systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry * ongoing intraabdominal infections * terminal illness * severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST \> 6 x upper limit of normal (ULN) and bilirubin \> 3 x ULN * severe renal insufficiency with a creatinine clearance ≤30 mL/min. * neutrophil count \< 1000 cells/mm3 * platelets \< 75000 cells/mm3 * coagulation studies (INR) \> 1.5 x ULN * ongoing chemotherapy and/or radiotherapy * ongoing therapy with valproin acid (in case of ertapenem administration).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid | within 24 h after administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of Adverse Events (total and per patient) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Number of Serious Adverse Events (total and per patient) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
Countries
Germany
Outcome results
None listed