Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia
研究概览
简要总结
This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.
Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
详细描述
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27%
Patients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%.
These data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise.
Then we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.
- •Requiring mechanical ventilation for more than 48 hours
- •Includes all patients with structural or metabolic coma
排除标准
- •Pregnant women
- •History of allergic reactions to ampicillin sulbactam
- •Patients admitted as potential organ donors
- •Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.
- •Hospital stay for more than 48 hours before intubation.
研究组 & 干预措施
Sultamicillin, Antibiotic Prophylaxis
Sultamicillin, Antibiotic Prophylaxis
干预措施: Sultamicillin (Drug)
Placebo
Physiologic Sodium Chloride Solution
干预措施: Sultamicillin (Drug)
结局指标
主要结局
Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia
时间窗: 2 years
To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours
次要结局
- Effect of antibiotic prophylaxis versus placebo on the incidence of other infections(2 years)