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

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis

Intervention: Amikacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Sabrina De Winter, PharmD, Principal Investigator, Affiliation: KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium


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

Clinical Details

Official title: Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with amikacin PK/PD target attainment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: December 2012
Last updated: February 10, 2015

Page last updated: August 20, 2015

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