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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 N├ęphrologie, Toulouse 31059, France
Additional Information

Starting date: June 2008
Last updated: January 23, 2013

Page last updated: August 23, 2015

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