NCT03716895Unknown不适用
Identifying Risk Factors for Complications in Severe Septic Shock
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Lactate clearance
研究概览
简要总结
Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019.
The primary goal is to look for risk factors associated with an increased in lactate clearance
Secondary goals are the following:
- To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
- To look for risk factors associated with an increase risk of Acute Kidney Injury.
- To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
- To look for risk factors associated with a decrease in Ventilator-free days.
- To look for risk factors associated with a decrease in Vasopressor-free days.
- To look for risk factors associated with an increase risk of in-hospital mortality.
- To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
- To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
- To compare and validate different risk scores in our cohort.
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
- •Adults older than 18 years old admitted to ICU with Severe Septic Shock
排除标准
- •Rejecting participation by not signing informed consent form.
结局指标
主要结局
Lactate clearance
时间窗: 30 days
Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L
次要结局
- Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy(28 days)
- Mechanical Ventilation-free days(28 days)
- Vasopressors-free days(28 days)
- Rate of Acute Kidney Injury(28 days)
- ICU length of stay(28 days)
- Hospital length of stay(30 days)
- Rate of In-hospital Mortality(30 days)
- Rate of Acute Respiratory Distress Syndrome(28 days)
- Rate of New Atrial Fibrilation(28 days)
研究者
Marc Vives
Clinical Research Lead. Department of Anesthesiology & Critical Care
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
研究点 (1)
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