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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT02365272
Collaborator
(none)
100
Enrollment
2
Arms
24
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: amikacin standard dose

amikacin in a single standard dose

Drug: Amikacin
Amikacin administered in a single dose for critical care patients
Active Comparator: amikacin dose for critical care patients

amikacin in a single dose for critical care patients

Drug: Amikacin
Amikacin administered in a single dose for critical care patients

Outcome Measures

Primary Outcome Measures

  1. Number of participants with amikacin PK/PD target attainment [Participants will be followed for the duration of hospital stay, an expected average of 5 weeks]

    The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration > 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Sabrina De Winter, PharmD, KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mevr Sabrina De Winter, PharmD - KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02365272
Other Study ID Numbers:
  • University Hospitals Leuven
First Posted:
Feb 18, 2015
Last Update Posted:
Feb 18, 2015
Last Verified:
Feb 1, 2015
Keywords provided by mevr Sabrina De Winter, PharmD - KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium, Universitaire Ziekenhuizen Leuven
pharmacokinetics
aminoglycosides
Additional relevant MeSH terms:
Sepsis
Emergencies
Amikacin

Study Results

No Results Posted as of Feb 18, 2015