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

NCT ID: NCT06319677

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-05-01

Brief 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.

Detailed Description

Extracorporeal Membrane Pulmonary Oxygenation (ECMO) is a temporary life-support system used to provide partial or complete organ support for adult patients with severe cardiopulmonary failure. ECMO stabilizes the vital signs of critically ill patients, allowing time for further management of the underlying disease. Effective pharmacologic treatment of the primary condition is crucial for successful patient outcomes.

Critically ill patients often exhibit significant variability in pharmacokinetics (PK) compared to the general population. Moreover, the use of extracorporeal therapeutic techniques like ECMO introduces further variability and unpredictability in drug behavior. This can result from factors such as drug depletion within ECMO circuits, altered drug distribution volumes, and reduced drug excretion.

Sepsis and septic shock due to infections like pneumonia are life-threatening conditions frequently requiring admission to intensive care units. Timely and effective antimicrobial therapy is vital to reduce morbidity and mortality. To investigate the impact of ECMO therapy on the PK and PD of antimicrobial drugs, this prospective observational study will collect blood samples from critically ill adult patients, both those receiving ECMO treatment and those not receiving it. The study will focus on various antimicrobial agents, including imipenem, vancomycin, piperacillin/tazobactam, ceftazidime/avibactam, cefoperazone/sulbactam, cefepime, ceftriaxone, ticlopidine, linezolid, tigecycline, amikacin, gentamicin, polymyxin, voriconazole, fluconazole, caspofungin, micafungin, levofloxacin, and moxifloxacin. Data collected will be used to develop a Population Pharmacokinetic and Pharmacodynamic model based on patient demographics, laboratory results, dosing information, and blood concentration data.

Conditions

Critical Illness; Extracorporeal Membrane Oxygenation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ECMO treatment group

Critically ill adult patients treated with ECMO using one or more antimicrobial agents

ECMO treatment

Intervention Type: DEVICE

Critically ill patients were treated with ECMO while receiving antimicrobial therapy

Non-ECMO treatment group

Critically ill adult patients using one or more antimicrobial agents not receving ECMO

No interventions assigned to this group

Interventions

ECMO treatment

Critically ill patients were treated with ECMO while receiving antimicrobial therapy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingjing Liu

Role: STUDY_CHAIR

Xiangya Third Hospital, Central South University

Locations

Xiangya Third Hospital, Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

Jingjing Liu, Doctor

Role: CONTACT

ivljingjing@126.com

+86 0731-88618170

Shengnan Zhang

Role: CONTACT

secnanzhang@gmail.com

+86 18084668240

Facility Contacts

Jingjing Liu, Doctor

Role: primary

ivljingjing@126.com

+86 0731-88618170

Other Identifiers

Ivljingjing

Identifier Type: -

Identifier Source: org_study_id