Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: June 20, 2008
Last updated: January 23, 2013
Last verified: January 2013
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

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

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

Enrollment: 10
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00703144

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

Responsible Party: University Hospital, Toulouse Identifier: NCT00703144     History of Changes
Other Study ID Numbers: 07 300 02
University Hospital Toulouse
Study First Received: June 20, 2008
Last Updated: January 23, 2013

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

Additional relevant MeSH terms:
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017