Vasopressor Use Improves Macrocirculation, But What Are Its Effects on Microcirculation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Central Venous Oxygen Saturation (ScvO₂) Level
研究概览
简要总结
To manage the treatment in the intensive care unit for patients with septic shock, central venous oxygen saturation (scvO2) is used as a macrocirculatory indicator, with a target value of 70% or higher being recommended. Tissue oxygenation (stO2) measurement can be implemented to assess the microcirculation in these patients, but a specific target value has not been established yet. The investigators believe that guiding the treatment of septic shock patients based on the measurement of microcirculation using stO2 and evaluating its correlation with scvO2 can reduce mortality.
This study aims to investigate the independent impact of high-dose norepinephrine on microvascular reactivity assessed by NIRS-VOT in patients with septic shock, while also examining how these microcirculatory indices relate to the macrocirculatory marker ScvO₂.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age 18 years or older
- •Diagnosis of septic shock
- •Receiving vasopressor and mechanical ventilation therapy
- •Presence of a central venous catheter that allows ScvO₂ sampling
- •Ability to obtain tissue oxygenation (stO₂) measurements using a NIRS probe placed on the thenar eminence
- •Written informed consent obtained from patient or legal representative
排除标准
- •Local infection, wound, or skin lesion at the planned NIRS probe application site
- •Mean arterial pressure (MAP) < 60 mmHg despite vasopressor therapy
- •Pregnancy
- •Inability to safely perform the vascular occlusion test (as judged by treating clinician)
- •Any condition preventing safe blood sampling or reliable stO₂ measurement
结局指标
主要结局
Central Venous Oxygen Saturation (ScvO₂) Level
时间窗: Baseline (first 1 hour)
Central venous oxygen saturation will be measured from a central venous blood gas sample. The ScvO₂ value obtained at baseline will be recorded.
Baseline Tissue Oxygen Saturation (stO₂_baseline)
时间窗: Within 1 hour of enrollment
Tissue oxygen saturation will be measured non-invasively from the thenar eminence using Near-Infrared Spectroscopy (NIRS). The baseline stO₂ value will be recorded immediately before the vascular occlusion test.
Norepinephrine Equivalent Vasopressor Dose
时间窗: Baseline (first 1 hour)
The vasopressor requirement will be expressed as the norepinephrine equivalent dose (NEq), calculated in µg/kg/min.
Minimum Tissue Oxygen Saturation During Vascular Occlusion (stO₂_min)
时间窗: Within 1 hour of enrollment
During the vascular occlusion test (inflation of a cuff to stop arterial inflow), the lowest tissue oxygen saturation (stO₂\_min) recorded from the NIRS probe on the thenar eminence will be measured and recorded.
Maximum Tissue Oxygen Saturation After Reperfusion (stO₂_max)
时间窗: Within 1 hour of enrollment
After release of the vascular occlusion, the highest tissue oxygen saturation (stO₂\_max) value recorded during reactive hyperemia will be measured and recorded.
Recovery Time (From stO₂_min to stO₂_max)
时间窗: Within 1 hour of enrollment
Recovery time will be defined as the time interval between the minimum tissue oxygen saturation (stO₂\_min) during vascular occlusion and the maximum tissue oxygen saturation (stO₂\_max) after cuff release, as measured by NIRS on the thenar eminence.
次要结局
- 28-Day All-Cause Mortality(28 days)
研究者
Oguz Özakın
Anesthesiology and Reanimation Specialist
Gaziosmanpasa Research and Education Hospital