Effect of vancomycin loading dose on AUC0-24 target attainment in pediatric sepsis patients

Phase 4

Recruiting

• Conditions: Pediatric sepsis patients; Intensive care units, pediatirc; Sepsis; Septic shock; Pharmacokinetics

• Registration Number: TCTR20210617001
• Lead Sponsor: Kritsaporn Sujjavorakul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Age 3 months to 18 years at the day of the first dose vancomycin
2. Pediatric sepsis patients
3. Informed consent by one parent or the legal guardian

Exclusion Criteria

1. Receiving extracorporeal organ support including hemodialysis, peritoneal dialysis (PD), continuous renal replacement therapy (CRRT), plasmapheresis, blood purification, artificial liver support systems, and extracorporeal membrane oxygenation (ECMO)
2. Previous vancomycin treatment within 1 weeks prior to the day of study in subject with normal kidney function at baseline or within 4 weeks prior to the day of study in subject with renal impairment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC/MIC 6 hours after first dose First order pharmacokinetic equations

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury 2 weeks modified Schwartz equation,AUC steady state 2 days First order pharmacokinetics equation