PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Third Xiangya Hospital of Central South University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ECMO treatment

    Device

    Critically ill patients were treated with ECMO while receiving antimicrobial therapy

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ECMO treatment group1 intervention
Group B: Non-ECMO treatment group0 interventions

Trial outcomes

Primary outcomes

1

Blood drug concentration

Plasma drug concentration

Time frame
Samples were taken in the first 72 hours after administration according to the sampling schedule
2

Pharmacokinetic parameter

Area under the plasma concentration-time curve(AUC)

Time frame
24 hours after administration
3

Pharmacokinetic parameter

Peak Plasma Concentration (Cmax)

Time frame
12 hours after administration

Secondary outcomes

1

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%.

Time frame
Day 30 of the patient's admission

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: