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Clinical Trials in China / NCT06319677
Starting soon Observational

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

NCT06319677 · tracked via the Priya Life Science China tracker
Sponsor
The Third Xiangya Hospital of Central South University
Phase
Observational
Started
2024-05-01
Last updated
2024-03-20

Condition(s) studied

Critical IllnessExtracorporeal Membrane Oxygenation Complication

Investigational drug(s) / intervention(s)

ECMO treatment

ECMO treatment: Critically ill patients were treated with ECMO while receiving antimicrobial therapy

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent was obtained from the patient or family member 2. Patients who are undergoing ECMO or not 3. Anti-infection treatment indications Exclusion Criteria: 1. Patients under 18 years of age or pregnant 2. Information on antimicrobial therapy and ECMO support is incomplete 3. Presence of other circumstances that make participation in this study inappropriate

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xiangya Third Hospital, Central South University Changsha Hunan

More The Third Xiangya Hospital of Central South University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06319677 on ClinicalTrials.gov ↗ ← All trials in China