Body Clearance, Diffusive and Convective Clearance, Piperacillin Tazocilline Concentrations (Cmin)
Conditions
Keywords
Pharmacokinetics, piperacillin/tazobactam., Septic patients, oliguric renal failure, continuous veno-venous hemodiafiltration.
Brief summary
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.
Detailed description
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. This is a prospective study. Continuous replacement therapy has a continuous effect on drug elimination which could compromise effective antibiotic treatment. Patients will receive a standard course of pip/tazo 4g intravenously 8 hourly administrated immediately when CVVHDF will be started. Blood samples will be collected at 30mn, 2h, 4h, 6h, 8h, 16h, 24h for the first and the second day. We will measure plasma piperacillin/tazobactam concentration and compare them to MICs for the whole dosing interval.
Interventions
DRUGpiperacillin/tazobactam
piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days
PROCEDUREPharmacokinetic
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older . * Females of childbearing potential must have a negative pregnancy test at screening. * Subjects whose life expectancy is estimated over 7 days. * Anuric patients requiring continuous venovenous hemodiafiltration * Septic patients,severe sepsis or septic shock * Written informed consent should be given either by the patient or a member of his family
Exclusion criteria
* Subjects with a history of true allergy or adverse drug reactions * Pathogens whose antibiotic susceptibility is not proved. * Patients having impaired hepatic function * Contraindication of anticoagulation by heparin * Residual renal function * Participation in a clinical trial * Interruption of treatment by piper/tazo or hemodiafiltration during the study. * Patients with psychiatric disorder or serious medical condition which in the opinion of the investigator may lead to complexity in patient management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| Body clearance | 2 days |
Countries
France
Outcome results
None listed