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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Sepsis

Treatments: Drug: Amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02365272

University Hospitals Leuven

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

amikacin standard dose

Active Comparator group

Description:

amikacin in a single standard dose

Treatment:

Drug: Amikacin

amikacin dose for critical care patients

Active Comparator group

Description:

amikacin in a single dose for critical care patients

Treatment:

Drug: Amikacin