Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock: Effects on Microcirculation and Organ Function.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- plasma protein C activity
研究概览
简要总结
The purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human Protein C concentrate in patients with sepsis and septic shock.
详细描述
Sixty septic patients with plasma protein C activity < 60 % will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous infusion of human Protein C concentrate at 3 UI/Kg/hr for 72 hours to reach plasma protein C activity between 70 and 120 % b)to a continuous infusion of activated protein C at 24 micrograms/Kg/hr for 96 hours, c) a standard teatment(control; each n = 20). In all groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization, from microcirculation (SDF imaging) and from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Severe sepsis or septic shock with plasma activity of protein C < 60 %
排除标准
- •Pregnancy
- •Risk of Bleeding
- •Hemorragia
- •age < 18
研究组 & 干预措施
Human protein C concentrate
干预措施: Human protein C concentrate (Drug)
activated protein C
Continuous infusion of Activated Protein C
干预措施: Activated protein C (Drug)
Placebo
Standard treatment
干预措施: Placebo comparator (Drug)
结局指标
主要结局
plasma protein C activity
时间窗: over a period of 72 hours
次要结局
- sublingual microcirculatory blood flow(over a period of 72 hours)
研究者
Andrea Morelli
associate professor
University of Roma La Sapienza