Using Fluorescence Angiography to Detect Occult Shock
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Skin Perfusion Value
研究概览
简要总结
The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).
详细描述
Hypoperfusion may be multifactorial, due to hemorrhage, shock or other disease processes resulting in either capillary leak into the interstitium or profound vasodilatation. Currently, diagnosis of hypoperfusion depends on indirect markers of perfusion such as lactate, blood pressure, creatinine, urine output, and mental status. These are all late signs of hypoperfusion as they are precursors to impending system failure. In this study, the focus will be on one of the most common causes of hypoperfusion in the surgical population; sepsis and septic shock.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Sepsis arm inclusion criteria:
- •Diagnosis of severe sepsis and septic shock.
- •Sepsis is defined as at least two of the following signs and symptoms (SIRS) that are both present and new to the patient and suspicion of new infection:
- •Hyperthermia >38.3°C or Hypothermia <36°C
- •Tachycardia >90 bpm
- •Tachypnea >20 bpm
- •Leukocytosis (>12,000 μL-1) or Leukopenia (<4,000 μL-1) or >10% bands.
- •Hyperglycemia (>120 mg/dl) in the absence of diabetes.
- •Severe sepsis includes SIRS and at least one of the following signs of hypoperfusion or organ dysfunction that is new and not explained by other known etiology of organ dysfunction:
- •Hypotension (<90/60 or MAP <65)
- •Lactate >2
- •Areas of mottled skin or capillary refill >3 seconds
- •Creatinine >2.0 mg/dl
- •Disseminated intravascular coagulation (DIC), Platelet count <100,000
- •Acute renal failure or urine output <0.5 ml/kg/hr for at least 2 hours
- •Hepatic dysfunction as evidenced by:
- •Bilirubin >2 or INR >1.5
- •Cardiac dysfunction
- •Acute lung injury or ARDS
- •Control arm inclusion criteria:
- •Do not have diagnosis of sepsis, severe sepsis, or septic shock
- •Are not on vasopressors
- •Are normo-thermic
排除标准
- •Sepsis arm exclusion criteria:
- •Iodide allergy
- •Control arm exclusion criteria:
- •Iodide allergy
- •Individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.
结局指标
主要结局
Skin Perfusion Value
时间窗: Up to 6 hours
We aim to obtain a SPI within 6 hours of enrollment. Skin perfusion images produced by LUNA have computerized, graded quantification of fluorescein intensity (values 0-256). The mean score will be used to compare Sepsis and Control arms.
次要结局
未报告次要终点