Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
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: No use of antibiotics, with antibiotics treatment.
- Кому может быть актуально
- Состояния в реестре: Infection, Bacterial, Out-Of-Hospital Cardiac Arrest. 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
- Катар
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Specific Aim : The specific aim is to conduct a randomized prospective clinical trial to determine whether no antibiotics in OHCA patients in the ED with very low likelihood of infection is non-inferior to early antibiotic treatment. Hypothesis a: 28-day all-cause mortality will be non-inferior in OHCA patients with very low likelihood of infection who do not receive antibiotic therapy compared with those who receive early antibiotic therapy Hypothesis b: There will be no difference in subsequent incidence of proven infections in the no antibiotics vs, early antibiotics groups Hypothesis c: There will be no difference in the length of ICU stay and overall hospital stay in the early antibiotics vs. no antibiotics groups
Подробное описание
As above
Вмешательства
- Другое No use of antibiotics
Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria - Другое with antibiotics treatment
with antibiotics treatment
Первичные конечные точки
- 28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not. [Срок оценки: 28-day]
Критерии участия
Критерии включения
- ● Adults aged >18 years, presenting to HGH ED after out-of-hospital cardiac arrest
- Patients with low likelihood of infection as per the definitions provided above
- Ability to obtain informed consent from the subjects or their next of kin/family member/legal surrogate in case of incapacitation due to sedation, mechanical ventilation, etc. In case the next of kin is not available, an independent physician who is not a part of the investigative team will complete and sign the checklist as per HMC Policy "RES 11026\_Appendix 6.5". (see section 4.1.3 for details) A member of the investigative team and a witness will also sign this form before the potential subject is enrolled in the study.
Критерии исключения
- Patients who have clear evidence of infection, as defined by criteria for the study.
- Patients who have received antibiotics within the last 1 week prior to admission.
- Patients with malignancy, except those who have been cured or in complete remission.
- Females with known pregnancy.
- Known immunocompromised states (including HIV/AIDS, transplant recipients on immunosuppressant drugs, long-term \[> 3 weeks of prednisone >5mg/day equivalent\] steroid therapy).
- Patients on immunologic disease modifying agents (commonly known as "biologics")
- Patients considered "brain-dead" or "vegetative state"
- Patients transferred from another hospital, long term care facility or institution
- Neutropenia (total WBC <1,500/mm3 or absolute neutrophil count of <1,000/mm3)
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
- Профилактика
Центры проведения
Катар · 1 центр
- Hamad Medical Corporation — Doha
Идентификаторы
NCT: NCT05914779 · IRGC-05-SI-18-356