Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

ConditionSepsis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-17
SponsorChildren's Hospital of Philadelphia

About this trial

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?

Eligibility criteria

Qualifiers

Age >1 month and <18 years

Weight >5kg and <50kg

Vancomycin intended duration of therapy ≥48 hours

Admitted to intensive care unit with suspected or confirmed sepsis

Disqualifiers

Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy

Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)>1

Central nervous system infection

Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)

Trial design

Treatments tested in this trial

  • personalized dosing adjustment of vancomycin

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator