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

T

Toulouse University Hospital

Status and phase

Completed
Phase 4

Conditions

Body Clearance
Piperacillin Tazocilline Concentrations (Cmin)
Diffusive and Convective Clearance

Treatments

Drug: piperacillin/tazobactam
Procedure: Pharmacokinetic

Study type

Interventional

Funder types

Other

Identifiers

NCT00703144
07 300 02
University Hospital Toulouse

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Pharmacokinetic
Experimental group
Treatment:
Drug: piperacillin/tazobactam
Procedure: Pharmacokinetic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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