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

Critical Illness Clinical Trial

— ECMO  

Official title:

PK/PD Study of Antibiotics in Critically Ill Patients Receiving ECMO

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319677
• Other study ID #: Ivljingjing
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: September 2023
• Source: The Third Xiangya Hospital of Central South University
• Contact: Jingjing Liu, Doctor
• Phone: +86 0731-88618170
• Email: ivljingjing[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Extracorporeal Membrane Oxygenation Complication

Intervention

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

Locations

Country	Name	City	State
China	Xiangya Third Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood drug concentration	Plasma drug concentration	Samples were taken in the first 72 hours after administration according to the sampling schedule
Primary	Pharmacokinetic parameter	Area under the plasma concentration-time curve(AUC)	24 hours after administration
Primary	Pharmacokinetic parameter	Peak Plasma Concentration (Cmax)	12 hours after administration
Secondary	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%.	Day 30 of the patient's admission