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

Not yet recruiting

• Conditions: Critical Illness; Extracorporeal Membrane Oxygenation Complication
• Interventions: Device: ECMO treatment

• Registration Number: NCT06319677
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Study Start: 2024-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECMO treatment group	ECMO treatment	Critically ill adult patients treated with ECMO using one or more antimicrobial agents

Primary Outcome Measures

Name	Time	Method
Blood drug concentration	Samples were taken in the first 72 hours after administration according to the sampling schedule	Plasma drug concentration
Pharmacokinetic parameter	12 hours after administration	Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Mortality at 14 and 28 days	Day 30 of the patient's admission	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%.

Trial Locations

Locations (1)

Xiangya Third Hospital, Central South University; 🇨🇳 Changsha, Hunan, China