THE Activated Protein C (aPC) TREATMENT IMPROVES MICROCIRCULATION IN SEVERE SEPSIS/ SEPTIC SHOCK SYNDROME
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Microcirculatory Flow Index (MFI) before during and after aPC infusion
研究概览
简要总结
Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves the microcirculation of severe septic patients.
Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis were included in a one year period.
Interventions: Patients who had no contraindication to aPC administration received aPC at a dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were considered as controls.
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
- •Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis
排除标准
- •hematologic or advanced malignancies
- •liver cirrhosis
- •severely impaired consciousness (Glasgow Coma Scale score <7 of 15)
- •therapeutic limitations (do-not-resuscitate orders)
结局指标
主要结局
Microcirculatory Flow Index (MFI) before during and after aPC infusion
时间窗: 102 hours
Microcirculatory Flow Index detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve MFI.
次要结局
- Tissue oxygen saturation (StO2) upslope before during and after aPC infusion(102 hours)
- Perfused Vessel Density before during and after aPC infusion(102 hours)
研究者
Abele Donati, MD
Associate Professor
Università Politecnica delle Marche