Trial of Antimicrobial Restraint in Presumed Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- protocol adherence
研究概览
简要总结
The objective of this cluster-randomized crossover study is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock.
详细描述
This study will involve 8 centers is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock. The study team will compare two sequential 4-month periods in each unit, one 'aggressive' antimicrobial initiation period and one 'conservative' antimicrobial initiation period.
This study will serve the following specific aims:
Specific Aim 1: To determine feasibility of a larger multicenter study of the same design as well as assess protocol adherence across multiple centers.
Specific Aim 2: Prospectively determine the all-cause, in-hospital mortality for all patients with suspected pneumonia who were treated under either an aggressive or conservative antimicrobial initiation protocol.
Specific Aim 3: Prospectively determine antimicrobial initiation rates, total days of antimicrobial administration, hospital and ICU length of stay, and ventilator-free alive days for patients treated under each protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated patients admitted to a surgical or trauma intensive care unit that have had an appropriate quantitative or semi-quantitative endobronchial sputum culture sent ≥48 hours into their ICU admission
- •Primary pathology managed by surgical specialty
- •Age ≥18 years.
排除标准
- •Non-intubated patients.
- •Intubated patients with concern for active infection that is not suspected to be pneumonia (i.e. intra-abdominal infection, skin and soft tissue infection, urinary tract infection, etc.)
- •Primary disease not surgical or traumatic in nature
- •Primary diagnosis of burns
- •Incarcerated status
- •Pregnant status or delivery during this hospitalization.
- •On active immunosuppressive medications (or taking as a home medication prior to arrival)
研究组 & 干预措施
Aggressive Arm
If an intubated patient is suspected of having an ICU-acquired HAP/VAP during the aggressive period, antimicrobials should be initiated immediately after quantitative or semi-quantitative endobronchial cultures are sent regardless of clinical status. This will include patients who, as determined by the attending intensivist, are in sepsis or septic shock. If, after 72 hours, cultures and other clinical data do not point to a pneumonia, the antimicrobials should be stopped in the absence of another source of infection.
干预措施: antimicrobial initiation (Other)
Conservative Arm
If a patient is suspected of having an ICU-acquired HAP/VAP during the conservative period, quantitative or semi-quantitative endobronchial cultures should be sent. If the patient is in septic shock persistent hypotension requiring vasoactive medications to maintain mean arterial pressure (MAP) ≥65 mm HG or persistent lactic acidosis (>2 mmol/L) despite adequate resuscitation) antimicrobials will be initiated immediately. If the patient has new onset organ dysfunction that is presumed to be due to infection (sepsis) then antimicrobials will be initiated at the discretion of the attending intensivist. In the absence of septic shock or sepsis (intensivist discretion), antimicrobials will not be initiated unless objective evidence of pneumonia is present or another documented source of infection is identified mandating treatment with antimicrobials.
干预措施: antimicrobial initiation (Other)
结局指标
主要结局
protocol adherence
时间窗: by time of culture finalization or 1 week
as a pilot study the primary outcome will be protocol adherence as defined by using the criteria below: Aggressive Protocol: * Failure to send appropriate culture before initiation of antimicrobials in the absence of septic shock * Failure to stop antimicrobials in the absence of pneumonia or other documented infection after 72 hours. Conservative Protocol: * Failure to send appropriate culture * Initiation of antimicrobials (in the absence of septic shock, new onset or worsening organ dysfunction, or other indicated source of infection) without any objective evidence of pneumonia. * Failure to initiate antimicrobials in the setting of objective evidence of pneumonia. * Failure to stop antimicrobials in the absence of other documented infection if final cultures return as negative.
次要结局
- ICU length of stay(Until discharge from ICU or 1 year)
- Days of antimicrobials administered(until hospital discharge or 1 year)
- Hospital length of stay(until hospital discharge or 1 year)
- In-hospital mortality(until hospital discharge or 1 year)
- Ventilator-free alive days(until hospital discharge or 1 year)