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

NCT ID: NCT00703144

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pharmacokinetic

Group Type EXPERIMENTAL

piperacillin/tazobactam

Intervention Type DRUG

piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days

Pharmacokinetic

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

piperacillin/tazobactam

piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days

Intervention Type DRUG

Pharmacokinetic

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tazocilline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

LAVAYSSIERE Laurence, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Néphrologie

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

University Hospital Toulouse

Identifier Type: -

Identifier Source: secondary_id

07 300 02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.