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