Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 16
- 主要终点
- Incidence reduction of early VAP
研究概览
简要总结
Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP).
Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.
详细描述
Multicenter add-on randomized controlled double-blind trial assessing the efficacy of preventive antibiotics amoxicillin-clavulanic acid vs placebo to prevent occurrence of early VAP after out-of-hospital cardiac arrest receiving mild therapeutic hypothermia, in addition to usual VAP prevention measures.
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
- Double (Participant, Investigator)
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
- •Older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
- •Hospitalized in an ICU
- •Mild therapeutic hypothermia procedure (32° to 35°C) scheduled (24 to 36 hours)
- •Delay from ROSC to randomisation < 6 hours
- •Consent from family members or emergency consent
排除标准
- •Pregnancy
- •Out-of-hospital cardiac arrest secondary to non shockable rhythm and In-hospital cardiac arrest
- •Need for cardiac support by cardiopulmonary bypass
- •Ongoing antibiotic therapy or during the week before
- •Ongoing or concomitant pneumonia
- •Known chronic colonization with MRB
- •Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.
- •History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
- •History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the SmPC.
- •Previous lung disease
- •Predictable decision of early care limitation
- •Patient under guardianship or curatorship
- •Moribund patient
- •Participation to another trial within 30 days
研究组 & 干预措施
Amoxicillin clavulanic acid
Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
干预措施: Amoxicillin - clavulanic acid (Drug)
Placebo
Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence reduction of early VAP
时间窗: 7 days
Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest
次要结局
- Mortality(28 days)
- Early nosocomial infectious complications(28 days)