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Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

Study acronym: VAST-i
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion pushed from Aug 15, 2026 to May 15, 2027
    • Study completion pushed from Dec 31, 2026 to May 31, 2027
    • Start date changed from estimate of Apr 2026 to Apr 15, 2026
    v6
  2. Notable Start date: Dec 2025 to Apr 2026v5
  3. Notable Start date: Sep 1, 2025 to Dec 2025v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 1, 2025 to Sep 1, 2025
    • Site details revised
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are: 1. Is it feasible to use personalized models of vancomycin dosing in children with sepsis? 2. Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?
Trial Details
NCT Number NCT07084129
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
Sepsis
Related terms Sepsis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov