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

Primary Purpose

Sepsis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Amikacin

About this trial

This is an interventional treatment trial for Sepsis focused on measuring pharmacokinetics, aminoglycosides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

amikacin standard dose

amikacin dose for critical care patients

Arm Description

amikacin in a single standard dose

amikacin in a single dose for critical care patients

Outcomes

Primary Outcome Measures

Number of participants with amikacin PK/PD target attainment

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02365272

First Posted

January 27, 2015

Last Updated

February 10, 2015

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT02365272

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

pharmacokinetics, aminoglycosides

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

amikacin standard dose

Arm Type

Active Comparator

Arm Description

amikacin in a single standard dose

Arm Title

amikacin dose for critical care patients

Arm Type

Active Comparator

Arm Description

amikacin in a single dose for critical care patients

Intervention Type

Drug

Intervention Name(s)

Amikacin

Intervention Description

Amikacin administered in a single dose for critical care patients

Primary Outcome Measure Information:

Title

Number of participants with amikacin PK/PD target attainment

Description

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabrina De Winter, PharmD

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

34297338

Citation

De Winter S, van Hest R, Dreesen E, Annaert P, Wauters J, Meersseman W, Van den Eede N, Desmet S, Verelst S, Vanbrabant P, Peetermans W, Spriet I. Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):653-663. doi: 10.1007/s13318-021-00698-w. Epub 2021 Jul 23.

Results Reference

derived

PubMed Identifier

29180278

Citation

De Winter S, Wauters J, Meersseman W, Verhaegen J, Van Wijngaerden E, Peetermans W, Annaert P, Verelst S, Spriet I. Higher versus standard amikacin single dose in emergency department patients with severe sepsis and septic shock: a randomised controlled trial. Int J Antimicrob Agents. 2018 Apr;51(4):562-570. doi: 10.1016/j.ijantimicag.2017.11.009. Epub 2017 Nov 24.

Results Reference

derived

Learn more about this trial

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

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