Pharmacokinetics of Piperacillin/Tazobactam in Patients Treated by Continuous Renal Replacement Therapy
Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diffusive and Convective Clearance; Body Clearance; Piperacillin Tazocilline Concentrations (Cmin)
Intervention: piperacillin/tazobactam (Drug); Pharmacokinetic (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s): LAVAYSSIERE Laurence, MD, Principal Investigator, Affiliation: University Hospital, Toulouse
Summary
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients
with renal failure undergoing continuous veno-venous hemodiafiltration.
Clinical Details
Official title: Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus
Secondary outcome: Body clearance
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Service de Néphrologie, Toulouse 31059, France
Additional Information
Starting date: June 2008
Last updated: January 23, 2013
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