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临床试验/NCT01187004
NCT01187004已完成不适用

Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
164
试验地点
1
主要终点
Acute Lung Injury After Cardiac Surgery

研究概览

简要总结

Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.

详细描述

To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cardiac intervention with cardiopulmonary by pass, age > 18 years old

排除标准

  • off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.

结局指标

主要结局

Acute Lung Injury After Cardiac Surgery

时间窗: at seven days after intervention

to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 \<300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.

次要结局

  • Intensive Care Unit (ICU) Length of Stay(at 28 days)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Pasero

MD

University of Turin, Italy

研究点 (1)

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