About this trial
The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic criteria for invasive fungal infections presenting to the intensive care unit (ICU) with probable or proved patients According to the 2021 EORTC/MSGERC guideline.
Requiring ECOM assistance.
Age 18 years.
Disqualifiers
Intolerance of L-AmB therapy.
Pregnancy.
Expected survival time <24 hours.
Lack of necessary data on patient demographics physiopathology, and clinical status.
Trial design
Single group
Treatments tested in this trial
Determination of blood drug concentration
Biological/VaccineCollecting blood samples from patients and determining blood drug concentrations. Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration. Then, the blood concentrations were determined according to the established method.
Treatment groups
Trial outcomes
Primary outcomes
Blood drug concentration of liposomal amphotericin B
Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. Then collecting blood samples from these patients. The blood concentrations of L-AmB were determined according to the established method.
Sponsors and contacts
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