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Набор скоро начнётся NCT06319677

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

— Наблюдательное Critical Illness Extracorporeal Membrane Oxygenation Complication

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ECMO treatment.
Кому может быть актуально
Состояния в реестре: Critical Illness, Extracorporeal Membrane Oxygenation Complication. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Blood drug concentration [Срок оценки: Samples were taken in the first 72 hours after administration according to the sampling schedule]
  • Pharmacokinetic parameter [Срок оценки: 24 hours after administration]
  • Pharmacokinetic parameter [Срок оценки: 12 hours after administration]
Вторичные конечные точки (1)
  • Mortality at 14 and 28 days [Срок оценки: Day 30 of the patient's admission]

Критерии участия

Критерии включения

  • Written informed consent was obtained from the patient or family member
  • Patients who are undergoing ECMO or not
  • Anti-infection treatment indications

Критерии исключения

  • Patients under 18 years of age or pregnant
  • Information on antimicrobial therapy and ECMO support is incomplete
  • Presence of other circumstances that make participation in this study inappropriate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Xiangya Third Hospital, Central South University — Чанша

Идентификаторы

NCT: NCT06319677 · Ivljingjing

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗