Prophylactic Versus Clinically-driven Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Value of C-reactive protein (CRP) at day three
研究概览
简要总结
The purpose of this study is to determine whether there is potential benefits of prophylactic antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated in intensive care unit with therapeutic hypothermia.
详细描述
Postresuscitation management of comatose survivors of out-of-hospital cardiac arrest (OHCA) significantly improved and "bundle of care" including therapeutic hypothermia, immediate coronary angiography, percutaneous coronary intervention (PCI) and contemporary intensive care nowadays leads to survival with good neurological recovery. Benefit of prophylactic antibiotics, which may suppress development of postresuscitation infection and especially early onset pneumonia and thereby decrease the severity of postresuscitation systemic inflammatory response, is controversial. Because of these uncertainties, the investigators performed a single-center randomized clinical trial comparing prophylactic versus clinically-driven administration of antibiotics in comatose survivors of OHCA. The investigators hypothesized that prophylactic antibiotics may decrease the severity of postresuscitation systemic inflammatory response by reducing the incidence of postresuscitation infection and especially pneumonia which was further addressed by repeat microbiological sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Female and male over 18 years old
- •Comatose survivors of out-of-hospital cardiac arrest treated in intensive care unit with therapeutic hypothermia
排除标准
- •Suspected or confirmed pregnancy
- •Allergy to amoxicillin-clavulanic acid
- •Tracheobronchial aspiration
- •Antibiotic therapy before cardiac arrest
- •Need of antibiotics due to other causes
- •Candidates for immediate veno-arterial extracorporeal membrane oxygenation (VA ECMO)
- •Patients in whom no active treatment was decided on admission
研究组 & 干预措施
Prophylactic antibiotic
Amoxicillin-Clavulanic acid 1.2g every 8h
干预措施: Amoxicillin-Clavulanic acid (Drug)
结局指标
主要结局
Value of C-reactive protein (CRP) at day three
时间窗: Three days after admission to Intensive care unit (ICU)
Expressed in milligram/litre (normal \<5 mg/L)
次要结局
- Appearance of pneumonia on chest X ray(Chest X ray was taken on admission and afterwards on daily basis during the stay in the intensive care unite but not longer than first week)
- Duration of mechanical ventilation(From the admission until spontaneous breathing . This was during ICU stay-one month)
- Survival with good neurological outcome(Up to six months after the event)
- Severity of systemic inflammatory response estimated by peak value of neutrophil Cluster of differentiation 64 (CD 64)(First measurement at admission in hospital and afterwards in 24 hours intervals in the first three days)
- Severity of systemic inflammatory response estimated by peak white blood cell count (WBC)(First measurement at admission in hospital and afterwards in 24 hours intervals during stay in the intensive care unite (ICU) but not longer then first seven days)
- Severity of systemic inflammatory response estimated by peak value of procalcitonin (PCT)(First measurement at admission in hospital and afterwards in 24 hours intervals during stay in the intensive care unite (ICU) but not longer then first seven days)
- Incidence of positive hemocultures(From the admission until the patient was transferred to the ward. This was always during the ICU stay-one month)
- Duration of tracheal intubation(From the day of admission until the extubation. This was always during the ICU stay- one month)
- Incidence of positive blind mini bronchoalveolar lavage (Mini-BAL) on day 3(Mini-BAL was performed on the third day after the sudden cardiac arrest)
- ICU stay(From the admission until the patient was transferred to ward, usually less than one month)
研究者
Marko Noc
MD, PhD
University Medical Centre Ljubljana