Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not.
研究概览
简要总结
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
详细描述
As above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● 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.
排除标准
- •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)
结局指标
主要结局
28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not.
时间窗: 28-day
Primary outcome measure is 28-day all-cause mortality in persons who receive no antibiotics compared with those who receive early antibiotics in OHCA patients.
次要结局
未报告次要终点
研究者
Adeel Ajwad Butt
Senior Consultant in Infectious Diseases
Hamad Medical Corporation