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

January 23, 2013 updated by: University Hospital, Toulouse

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Service de néphrologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Tazocilline
Procedure: Pharmacokinetic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Body clearance
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: LAVAYSSIERE Laurence, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (ESTIMATE)

June 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07 300 02
  • University Hospital Toulouse (Other Grant/Funding Number: 14731802)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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