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

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ClinicalTrials.gov Identifier: NCT00703144
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diffusive and Convective Clearance Body Clearance Piperacillin Tazocilline Concentrations (Cmin) Drug: piperacillin/tazobactam Procedure: Pharmacokinetic Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration
Study Start Date : June 2008
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pharmacokinetic Drug: piperacillin/tazobactam
piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days
Other Name: Tazocilline
Procedure: Pharmacokinetic


Outcome Measures

Primary Outcome Measures :
  1. Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Body clearance [ Time Frame: 2 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703144


Locations
France
Service de Néphrologie
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: LAVAYSSIERE Laurence, MD University Hospital, Toulouse
More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00703144     History of Changes
Other Study ID Numbers: 07 300 02
University Hospital Toulouse
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by University Hospital, Toulouse:
Pharmacokinetics
piperacillin/tazobactam.
Septic patients
oliguric renal failure
continuous veno-venous hemodiafiltration.

Additional relevant MeSH terms:
Tazobactam
Penicillanic Acid
Piperacillin
Piperacillin, tazobactam drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action