Improving the Assessment of Microcirculatory Dysfunction in Septic Shock Patients Using Optical Coherence Tomography Angiography at the Bedside
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 28-days All-Cause Mortality
研究概览
简要总结
Purpose and rationale: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major public health problems killing one in every three patients. Microcirculatory dysfunction is frequent in septic shock. The duration and severity of this dysfunction have a prognostic impact by being associated with organ failure and mortality. Our study purposes to demonstrate the feasibility of optical coherence tomography angiography (OCTA) to improve assessment of microcirculatory dysfunction by showing that retinal and choroidal microcirculatory changes with prognostic impact are present during septic shock.
Primary objective: To characterize the alterations of retinal and choroidal microcirculation in septic shock.
We will test the hypothesis that retinal and/or choroidal microcirculation shows dysfunctional changes (lower vascular density, lower percentage of perfused small vessel, lower blood flow index and higher vascular heterogeneity) in septic shock patients.
Secondary objective: To test the prognostic value of retinal and choroidal microcirculatory dysfunction in septic shock.
We will test the hypothesis that higher magnitude and persistence of retinal and/or choroidal microcirculatory dysfunction beyond the successful macro-hemodynamic resuscitation are independent predictors of organ failure and mortality in septic shock patients.
Study type: Two sequential observational studies.
Study design: A cross-sectional case-control study followed by a prospective cohort study with a 90-days longitudinal follow-up period.
Study population: 165 septic shock patients and 30 healthy controls.
Study duration: 90 days from enrolment to final follow-up assessment. One to two years of enrolment.
详细描述
Purpose and rationale: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major public health problems killing one in every three patients. Microcirculatory dysfunction is frequent in septic shock. The duration and severity of this dysfunction have a prognostic impact by being associated with organ failure and mortality. Our study purposes to demonstrate the feasibility of OCTA to improve assessment of microcirculatory dysfunction by showing that retinal and choroidal microcirculatory changes with prognostic impact are present during septic shock.
Primary objective (specific aim 1): To characterize the alterations of retinal and choroidal microcirculation in septic shock.
We will test the hypothesis that retinal and/or choroidal microcirculation shows dysfunctional changes (lower vascular density, lower percentage of perfused small vessel, lower blood flow index and higher vascular heterogeneity) in septic shock patients.
Secondary objective (specific aim 2): To test the prognostic value of retinal and choroidal microcirculatory dysfunction in septic shock.
We will test the hypothesis that higher magnitude and persistence of retinal and/or choroidal microcirculatory dysfunction beyond the successful macro-hemodynamic resuscitation are independent predictors of organ failure and mortality in septic shock patients.
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
- 是
入选标准
- •≥ 18 years-old
- •septic shock diagnosis (defined by the presence of sepsis according to Sepsis-3 definition plus a SOFA score ≥ 3 points at cardiovascular system despite adequate volume resuscitation) less than 24 hours before the first OCTA assessment
排除标准
- •Inability or willingness to provide informed consent from the patient or next of kin
- •Shock due to any other cause without septic shock
- •Bilateral eye absence
- •Previously known retinopathy
- •Previous retinal surgery or photocoagulation
- •Pregnant women
- •Participants with psychiatry disorders
研究组 & 干预措施
Septic Shock Survivors
干预措施: Optical Coherence Tomography Angiography (Diagnostic Test)
Septic Shock Non-Survivors
干预措施: Optical Coherence Tomography Angiography (Diagnostic Test)
结局指标
主要结局
28-days All-Cause Mortality
时间窗: 28-days after enrollment
Percentage of Perfused Small Vessel (PPV)
时间窗: Daily assessment from day 0 to a maximum of 7 days
The absolute number of completely perfused small vessels (diameter \< 20μm) divided by the absolute number of small vessels (diameter \< 20μm).
次要结局
- Blood Flow Index (BFI)(Daily assessment from day 0 to a maximum of 7 days)
- ICU mortality(90-days after enrollment)
- Hospital length of stay(90-days after enrollment)
- Heterogeneity Index(Daily assessment from day 0 to a maximum of 7 days)
- Ventilator free-days(90-days after enrollment)
- Vasopressor free-days(90-days after enrollment)
- Hospital mortality(90-days after enrollment)
- Renal replacement therapy free-days(90-days after enrollment)
- Perfused Small Vessel Density (PVD)(Daily assessment from day 0 to a maximum of 7 days)
- ICU length of stay(90-days after enrollment)