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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
personalized dosing adjustment of vancomycin
Other interventionA personalized vancomycin PK model that incorporates kidney injury biomarkers will be used for vancomycin dose adjustments to achieve goal AUC levels.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Personalized vancomycin Pharmacokinetic model for dose adjustmentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - personalized dose adjustment performed
Percentage of enrolled patients in which urinary neutrophil gelatinase-associated lipocalin is measured and used to make a vancomycin dosing recommendation
Time frame
From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollmentSecondary outcomes
1
Feasibility - Use of study-determined empiric vancomycin dosing
Percentage of patients transitioned to the study-determined empiric vancomycin dosing.
Time frame
From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment2
Feasibility - Area under the curve sampling attainment on study empiric vancomycin dosing
Percentage of patients transitioned to the study-determined empiric vancomycin dosing and undergo subsequent area under the curve sampling.
Time frame
From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment3
Feasibility - Dosing change based on urinary neutrophil gelatinase-associated lipocalin level
Percentage of patients enrolled in which urinary neutrophil gelatinase-associated lipocalin is used to make a dosing recommendation and results in administration of at least one adjusted dose of vancomycin.
Time frame
From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment4
Feasibility - Area under the curve sampling attainment after personalized dose adjustment
Percentage of patients who undergo dose adjustment and have subsequent area under the curve sampling performed
Time frame
From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov