Optimizing Fluid Management Informed by Ultrasound for Patients With Sepsis
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge
研究概览
简要总结
Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit. The primary determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid deresuscitation in critically ill patients with sepsis reduces net fluid balance at 5 days as compared to usual care.
详细描述
Physicians can assess venous congestions with point of care ultrasound of intraabdominal veins using the venous excess in ultrasound score (VExUS), which has been shown to predict the harmful effects of volume overload. We seek to determine if VExUS-guided deresuscitation reduces the fluid balance in critically ill patients with sepsis as compared to usual care. This score compiles findings from the inferior vena cava, hepatic vein Doppler waveform, portal vein Doppler waveform, and intrarenal vein Doppler waveform:
Grade 0: IVC < 2cm, normal pattern in flow patterns of hepatic, portal, and intrarenal veins Grade 1: IVC ≥ 2cm, normal patterns or mild abnormalities in flow patterns of hepatic, portal, and intrarenal veins.
Grade 2: IVC ≥ 2cm, severe venous flow pattern in one among hepatic, portal, and intrarenal veins.
Grade 3: IVC ≥ 2cm, severe venous flow pattern in multiple among hepatic, portal, and intrarenal veins.
After informed consent, subjects will be randomized in a 1:1 ratio to the VExUS-guided intervention arm vs control arm. Subjects in both arms will undergo daily ultrasound, and the investigator will calculate the VExUS immediately after ultrasounds are obtained.
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
- 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
- •Must be suspected by the treating physician to have sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria:
- •Temperature of > 38 C or < 36 C
- •Heart rate of > 90/min
- •Respiratory rate of > 20/min or PaCO2 < 32 mm Hg
- •White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands.
- •Known or suspected infection at the time of screening
- •Admission to the ICU for <24 hours
- •Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria, SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock.
排除标准
- •Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis
- •Patients with severe chronic kidney disease (estimated glomerular filtration rate<15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula).
- •Age < 18 years
- •Active atrial fibrillation or atrial flutter
- •Hemodynamic instability due to active hemorrhage
- •Acute cerebral vascular event
- •Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)
- •Acute pulmonary edema
- •Status asthmaticus
- •Drug overdose
- •Injury from burn or trauma
- •Status epilepticus
- •Indication for immediate surgery
- •Received CPR within 24 hours of enrollment
- •Incarceration.
研究组 & 干预措施
VExUS-Guided Arm
Will receive 24 hour fluid balance target based on daily VExUS score.
干预措施: VExUS score (Diagnostic Test)
Usual Care Control Arm
Treating team will be blinded to results of daily VExUS score and will set 24 hour fluid balance target based on usual care.
结局指标
主要结局
Cumulative Fluid Balance at 5 days post ICU discharge or ICU Discharge
时间窗: At 5 days post ICU admission or ICU discharge, whichever comes first
Total fluid balance (ins minus outs)
次要结局
- Daily Sonographic B Line Measurement(study enrollment to ICU discharge or 5 days post-enrollment, whichever comes first)
- Incidence of respiratory failure(At 5 days post ICU admission or ICU discharge, whichever comes first)
- Change in SOFA score(At 5 days post ICU admission or ICU discharge, whichever comes first)
- 28-day and in-hospital mortality(28 days and during hospital admission up to 24 weeks)
- Incidence of Acute Kidney Injury(At 5 days post ICU admission or ICU discharge, whichever comes first)
- ICU discharge fluid balance(From ICU admission to ICU discharge or 30 days after ICU admission, whichever comes first)