Меню
Идёт набор NCT03368092

Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma

Фаза III С лечением Multiple Trauma Respiratory Distress Syndrome, Adult

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: Dornase Alfa Inhalant Solution [Pulmozyme], Placebos.
Кому может быть актуально
Состояния в реестре: Multiple Trauma, Respiratory Distress Syndrome, Adult. 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
Франция
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

A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit

Обзор

Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS). Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU). The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%). The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo: * an improvement in static lung compliance * a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days * a reduction in the length of ICU stay * a reduction in the hospital length of stay * a reduction in multi-organ failure * a reduction in ventilator-associated pneumonia (VAP) * a reduction in mortality at day 28

Вмешательства

  • Препарат Dornase Alfa Inhalant Solution [Pulmozyme]
    Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
  • Препарат Placebos
    NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.

Первичные конечные точки

  • The primary endpoint is the incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition [ARDS definition task force et al. JAMA 2015; 307(23): 2526-2533]) in severe trauma patients (Injury Severity Score > 15). [Срок оценки: Day 0 to Day 7]
Вторичные конечные точки (7)
  • Static lung compliance [mL/cmH2O] [Срок оценки: Day 0 to Day 7]
  • Duration of mechanical ventilation [hours] [Срок оценки: Day 0 to Day 7]
  • Length of ICU stay [hours] [Срок оценки: Day 0 to Day 7]
  • Length of stay in the hospital [days] [Срок оценки: Day 0 to Day 7]
  • Incidence of multi-organ failure [Срок оценки: Day 0 to Day 7]
  • Incidence of Ventilator-Associated Pneumonia (VAP) [Срок оценки: Day 0 to Day 7]
  • Mortality on day 28 [Срок оценки: Day 28]

Критерии участия

Критерии включения

  • Adult (>18) patient of either sex affiliated to the National Health Service
  • Severe trauma patient (either blunt or penetrating), Injury Severity Score > 15
  • Under mechanical ventilation for an expected duration > 48h
  • Admitted in the ICU
  • Signed informed consent from the patient's relative
  • Patient equipped with an indwelling arterial catheter

Критерии исключения

  • Pregnancy or breast feeding
  • Opposition from the patient or his/her relatives
  • Protected major (Guardianship)
  • Contraindication to the use of dornase alfa
  • Known intolerance to dornase alfa

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • University Hospital, Strasbourg, france — Strasbourg

Публикации

  • Pottecher J, Noll E, Borel M, Audibert G, Gette S, Meyer C, Gaertner E, Legros V, Carapito R, Uring-Lambert B, Sauleau E, Land WG, Bahram S, Meyer A, Geny B, Diemunsch P. Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patie PMID 32183886

Идентификаторы

NCT: NCT03368092 · 6998

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗