Target-controlled Infusion Model for Cefepime

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2019-02-28

Brief Summary

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For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.

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Detailed Description

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Conditions

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Antimicrobial Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCI group

Patients who receive cefepime based on TCI for a maximum of 5 days with a target concentration of cefepime of 16 mg/L.

Group Type EXPERIMENTAL

TCI group

Intervention Type OTHER

Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software

Interventions

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TCI group

Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment
* Patients within the weight range of 50 -120kg
* Patients with calculated creatinine clearance within the range 15 to \> 90 ml/min, allocated to one of three groups as described above.
* Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible.
* Patient with an arterial catheter in place for other reason than the current study purpose

Exclusion Criteria

* Patients displaying acute or chronic renal failure requiring renal replacement therapy
* Pregnancy
* Moribund patients
* Known sensitivity or allergy to cefepime
* Inclusion in another study involving antimicrobial treatment.
* Patient participating in a research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.
* Patient already previously included in the trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No