Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Determination of blood drug concentration

    Biological/Vaccine

    Collecting 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

30 Participants
are divided into 1 treatment group
Group A: L-AmB groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration.

Secondary outcomes

Other outcomes

Sponsors and contacts

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