About this trial
Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent was obtained from the patient or family member
Patients who are undergoing ECMO or not
Anti-infection treatment indications
Disqualifiers
Patients under 18 years of age or pregnant
Information on antimicrobial therapy and ECMO support is incomplete
Presence of other circumstances that make participation in this study inappropriate
Trial population
Critically ill adult patients using one or more antimicrobial agents receiving or not receiving ECMO
Trial design
Cohort
Prospective
Treatments tested in this trial
ECMO treatment
DeviceCritically ill patients were treated with ECMO while receiving antimicrobial therapy
Treatment groups
Trial outcomes
Primary outcomes
Blood drug concentration
Plasma drug concentration
Pharmacokinetic parameter
Area under the plasma concentration-time curve(AUC)
Pharmacokinetic parameter
Peak Plasma Concentration (Cmax)
Secondary outcomes
Mortality at 14 and 28 days
Mortality was measured by dividing the number of subjects who died during the observation period by the total number of subjects and multiplying by 100%.
Sponsors and contacts
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