Effects on the Septic Patient's Microcirculation of the Transfusion of Three Different Types of Concentrated Red Blood Cells.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Microcirculatory Flow Index (MFI) before and after blood transfusion.
研究概览
简要总结
Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three types of RBCs: 1- fresh standard RBCs (storage <10 days); 2-leukodepleted RBCs and 3-old standard RBCs (storage >15 days) respectively. Before and 1 hour after the transfusion, microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate, mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.
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
- •Patients with sepsis, severe sepsis or septic shock who, according to clinical evaluation, need a hemotransfusion.
排除标准
- •Patients under 18 years of age; Pregnancy; Coagulative disorders; Cardiogenic shock (Met<4;)Acute massive bleeding (>8 U)
结局指标
主要结局
Microcirculatory Flow Index (MFI) before and after blood transfusion.
时间窗: One hour after the end of blood transfusion compared with before blood transfusion
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
- Perfused Vessel Density (PVD)(One hour after the end of blood transfusion compared with before blood transfusion)
- StO2 upslope(One hour after the end of blood transfusion compared with before blood transfusion)
- Arterial Blood Lactate(One hour after the end of blood transfusion compared with before blood transfusion)
- Arterial pH(One hour after the end of blood transfusion compared with before blood transfusion)
- SOFA score(One hour after the end of blood transfusion compared with before blood transfusion)
研究者
Abele Donati, MD
Associate Professor
Università Politecnica delle Marche