Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Vascular reactivity measured with dose-response to phenylephrine
研究概览
简要总结
The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).
This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 with septic shock as determined by standard criteria (including infection and severe infection)
排除标准
- •Pregnant women
- •Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
- •Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy >= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count < 30000 x 10^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
研究组 & 干预措施
Shock + Treatment
Patients treated with activated protein C
干预措施: Recombinant Activated Protein C (Drug)
Shock + Treatment
Patients treated with activated protein C
干预措施: Near-infrared spectroscopy (NIRS) (Device)
Shock + Treatment
Patients treated with activated protein C
干预措施: Phenylephrine (Drug)
Shock + Treatment
Patients treated with activated protein C
干预措施: Blood sample (Biological)
Shock
Patients not treated with activated protein C
干预措施: Near-infrared spectroscopy (NIRS) (Device)
Shock
Patients not treated with activated protein C
干预措施: Phenylephrine (Drug)
Shock
Patients not treated with activated protein C
干预措施: Blood sample (Biological)
结局指标
主要结局
Vascular reactivity measured with dose-response to phenylephrine
时间窗: 24 hours
次要结局
未报告次要终点