Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amikacin standard dose

amikacin in a single standard dose

Group Type ACTIVE_COMPARATOR

Amikacin

Intervention Type DRUG

Amikacin administered in a single dose for critical care patients

amikacin dose for critical care patients

amikacin in a single dose for critical care patients

Group Type ACTIVE_COMPARATOR

Amikacin

Intervention Type DRUG

Amikacin administered in a single dose for critical care patients

Interventions

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Amikacin

Amikacin administered in a single dose for critical care patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied

Exclusion Criteria

* \< 18 years
* pregnancy
* burns
* amikacin treatment in the previous 2 weeks
* known allergy to aminoglycosides
* Do Not Reanimate Code ≥ 2
* Hospitalized patients with a prolonged deep venous or arterial catheder
* Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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mevr Sabrina De Winter

PharmD - KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium

Responsibility Role PRINCIPAL_INVESTIGATOR