Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to give a medicine called vancomycin more safely and effectively to children with sepsis, a serious infection that can affect the whole body. Vancomycin helps fight infection, but if the levels in the blood are too low, it may not work well, and if the levels are too high, it can harm the kidneys. Children with sepsis may process the medicine differently, so the usual way of deciding the dose might not always be the best. This study aims to see if using new, personalized dosing methods that consider each child’s kidney function can help doctors choose the right amount of vancomycin to give.

Children who are between 1 month and 18 years old, weigh between 5 and 50 kilograms (about 11 to 110 pounds), and are in the intensive care unit with sepsis may be eligible to join. They also need to be expected to receive vancomycin for at least two days and have certain signs of organ problems caused by sepsis. If a child’s kidney function is already very poor, or if they have other specific conditions like certain infections or are on dialysis, they would not be able to participate. If a child joins the study, doctors will use these new dosing methods to find the right amount of vancomycin and check blood levels to see if they fall within the safe and effective range. This study is not yet recruiting participants but aims to improve how children with sepsis are treated with vancomycin in the future.

Gender

ALL

Eligibility criteria

• 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