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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00703144
First received: June 20, 2008
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body clearance [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014