Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Area under the ROC curve of the CPIS score
研究概览
简要总结
The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined.
详细描述
New onset of pulmonary infiltrates, fever, and an increase in white blood cell (WBC) count accompanied by purulent tracheal secretions are clinically indicative of hospital-associated pneumonia (HAP). The low specificity and sensibility of diagnostic tests for HAP, however, tends to result in an extremely high incidence of missed diagnoses and may lay to high mortality.
The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined, because early organ dysfunction may be the first symptoms noted by clinicians.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients after cardiac/thoracic surgery with suspicion of HAP defined by the presence of the following criteria:
- •new onset of pulmonary infiltrates,
- •fever >38,3°C,
- •increase in white blood cell (WBC) count
- •purulent tracheal secretions
- •but also:
- •increased use of catecholamine,
- •need of volemic expansion,
- •depletion inability,
- •confusion,
- •hepatic perturbation with increased gamma-glutamyl transpeptidase (GGT)>2N or alkaline phosphatase (ALP) >1.5 N, or bilirubin >1.5N, or aminotransferase (AST or ALT>2 N).
排除标准
- •pregnancy,
- •end of life.
结局指标
主要结局
Area under the ROC curve of the CPIS score
时间窗: the previous 12 hours up to performance of pulmonary bacteriological samples
The CPIS score is based on six variables: * Fever * Leukocytosis * Tracheal aspirates * Oxygenation * Radiographic infiltrates * Cult of tracheal aspirates
次要结局
- Area under the ROC curve of increased need a volemic expansion and their positive and negative predictive values(the previous 12 hours up to performance of pulmonary bacteriological samples)
- Area under the ROC curve of confusion and their positive and negative predictive values(the previous 12 hours up to performance of pulmonary bacteriological samples)
- Area under the ROC curve of depletion inability and their positive and negative predictive values(the previous 12 hours up to performance of pulmonary bacteriological samples)
- Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values(the previous 12 hours up to performance of pulmonary bacteriological samples)
- Area under the ROC curve of hepatic perturbation and their positive and negative predictive values(the previous 12 hours up to performance of pulmonary bacteriological samples)
- Mortality(28 days)