Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

Phase 1RecruitingNCT07084129

Children's Hospital of Philadelphia20 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sepsis

Eligibility

Sex: ALLMin age: 1 MonthMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>1 month and \<18 years 2. Weight \>5kg and \<50kg 3. Vancomycin intended duration of therapy ≥48 hours 4. Admitted to intensive care unit with suspected or confirmed sepsis 5. Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment) Exclusion Criteria: 1. Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy 2. Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\>1 3. Central nervous system infection 4. Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy) 5. Pregnancy 6. Patients on chronic dialysis therapy 7. Patients with known history of delayed vancomycin clearance based on local pharmacy records

Outcomes

Primary Outcomes

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 enrollment

Secondary Outcomes

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 enrollment

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.