Pharmacokinetics of Piperacillin/Tazobactam in Patients Treated by Continuous Renal Replacement Therapy

Study Overview
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Brief Summary
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The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.

Detailed Description
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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.

Official Title
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Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration

Conditions
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Diffusive and Convective Clearance, Body Clearance, Piperacillin Tazocilline Concentrations (Cmin)

Intervention / Treatment
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* Drug: piperacillin/tazobactam
* Procedure: Pharmacokinetic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetic<br> | Drug: piperacillin/tazobactam<br>* piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days<br>* Other names: Tazocilline;Procedure: Pharmacokinetic<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body clearance |  | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, piperacillin/tazobactam., Septic patients, oliguric renal failure, continuous veno-venous hemodiafiltration.