Меню
Идёт набор NCT07532174

Efferon LPS Hemoadsorption in Cardiac Surgery Patients

Без фазы С лечением Cardiac Disease Multiple Organ Dysfunction Syndrome

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: Efferon LPS.
Кому может быть актуально
Состояния в реестре: Cardiac Disease, Multiple Organ Dysfunction Syndrome. 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
Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Intraoperative and Early Postoperative Use of Lipopolysaccharide Adsorption (Efferon LPS) in Cardiac Surgery Patients to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period

Обзор

This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period. Each patient in the treatment group will undergo two hemoadsorption sessions: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.

Подробное описание

Annually, over 1 million people worldwide undergo cardiac surgery. Most cardiac procedures still require cardiopulmonary bypass (CPB), myocardial protection during aortic cross-clamping, and the induction of cardioplegic arrest by administering cardioplegic solutions into the coronary circulation. All of these factors contribute to ischemia-reperfusion injury of the myocardium, which remains a leading cause of acute heart failure following the restoration of spontaneous circulation and, consequently, the development of post-perfusion multiple organ dysfunction, particularly acute kidney injury (AKI).

AKI occurs in approximately 7% of all hospitalized patients, 30% of intensive care unit patients, and up to 30% of patients undergoing cardiac surgery. Endotoxemia is one of the major contributors to the development of AKI. Septic AKI, compared with non-septic AKI, is associated with poorer prognosis, longer hospital stays, and lower survival rates.

The goal of the study is to evaluate the safety and efficacy of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period.

Вмешательства

  • Устройство Efferon LPS
    Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Efferon LPS hemoadsorption will be performed twice: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.

Первичные конечные точки

  • SOFA [Срок оценки: 1-7 days]
Вторичные конечные точки (6)
  • Vasopressor free days [Срок оценки: 1-28 days]
  • Renal replacement therapy (RRT) duration [Срок оценки: 1-28 days]
  • Mechanical ventilation duration [Срок оценки: 1-28 days]
  • Length of stay in the intensive care unit [Срок оценки: 1-28 days]
  • 28 days mortality [Срок оценки: 1-28 days]
  • Incidence of postoperative complications [Срок оценки: 1-28 days]

Критерии участия

Критерии включения

  • Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
  • EuroSCORE II ≥6%

Критерии исключения

  • Procalcitonin ≥2 ng/mL
  • Severe chronic liver disease, defined as Child-Pugh class C (>10 points) or clinically manifest hepatic failure
  • Dialysis-dependent chronic kidney disease (CKD)
  • Ongoing immunosuppressive therapy, including corticosteroids or cytotoxic agents, excluding standard perioperative medications
  • Any other clinical condition that, in the investigator's opinion, would preclude the patient's participation in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Россия · 3 центра
  • Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary" — Barnaul
  • Almazov National Medical Research Centre — Saint Petersburg
  • Pavlov First Saint Petersburg State Medical University — Saint Petersburg

Идентификаторы

NCT: NCT07532174 · efferon-lps-2024-04.1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗