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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMO treatment group | Critically ill adult patients treated with ECMO using one or more antimicrobial agents |
| |
| Non-ECMO treatment group | Critically ill adult patients using one or more antimicrobial agents not receving ECMO |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECMO treatment | Device | Critically ill patients were treated with ECMO while receiving antimicrobial therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood drug concentration | Plasma drug concentration | Samples were taken in the first 72 hours after administration according to the sampling schedule |
| Pharmacokinetic parameter | Area under the plasma concentration-time curve(AUC) | 24 hours after administration |
| Pharmacokinetic parameter | Peak Plasma Concentration (Cmax) | 12 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill adult patients using one or more antimicrobial agents receiving or not receiving ECMO
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Liu, Doctor | Contact | +86 0731-88618170 | ivljingjing@126.com | |
| Shengnan Zhang | Contact | +86 18084668240 | secnanzhang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingjing Liu | Xiangya Third Hospital, Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Third Hospital, Central South University | Changsha | Hunan | China |
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Blood samples collected before and after dosing according to sampling protocol.Each sample will be about 1-2 mL, for a total of about 12 mL.
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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