Precision Dosing of Vancomycin in Critically Ill Children

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborators: Belgium Health Care Knowledge Centre; Ghent University, Belgium
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• age: 0-15 years

• admitted to ICU or PHO unit

• suspected or confirmed Gram positive infection

• planned to start on intravenous intermittent or continuous infusion vancomycin treatment

• informed consent signed by parents or legal representatives

• not previously enrolled in this trial

Exclusion Criteria:

• extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)

• n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening)

• Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months or GFR < 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation

• patient death is deemed imminent and inevitable