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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210617001
Enrollment
78
Registered
2021-06-17
Start date
2021-07-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric sepsis patients Intensive care units, pediatirc Sepsis Septic shock Pharmacokinetics

Interventions

Standard dosing of vancomycin 15 mg/kg/dose intravenous infusion over 1 hours every 6 hours (total daily dose 60 mg/kg/day). Maximum daily dose in this group will be limited at 3000 mg/day.,A loading
Active Comparator Drug,Experimental Drug
Standard dose,Loading dose

Sponsors

Kritsaporn Sujjavorakul
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 18 Years

Inclusion criteria

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

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. 3. Stage 3 AKI 4. untreatable underlying diseases expected to result in death within 90 days.

Design outcomes

Primary

MeasureTime frame
AUC/MIC 6 hours after first dose First order pharmacokinetic equations

Secondary

MeasureTime frame
Acute kidney injury 2 weeks modified Schwartz equation,AUC steady state 2 days First order pharmacokinetics equation,Mortality 90 days Count

Countries

Thailand

Contacts

Public ContactKritsaporn Sujjavorakul

King Chulalongkorn Memorial Hospital

k.sujjavorakul@gmail.com0897909107

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026