Using Fluorescence Angiography to Detect Occult Shock

Study Overview
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Brief Summary
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The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).

Detailed Description
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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.

Official Title
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Using Fluorescence Angiography to Detect Occult Shock

Conditions
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Hypoperfusion

Intervention / Treatment
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* Device: skin perfusion image


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Sepsis arm exclusion criteria: Pregnant Iodide allergy Burns Control arm exclusion criteria: Pregnant Iodide allergy Burns Individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis Group<br>This group will consist of surgical intensive care patients with diagnosis of sepsis, severe sepsis, or septic shock. | Device: skin perfusion image<br>* Upon enrollment following written, informed consent, the patient will receive an injection of 7.5 mg of Indocyanine Green (ICG) intravenously (Dilute 25 mg of Indocyanine Green (ICG) with 10 cc of solvent to achieve a 2.5 mg/cc concentration.) Following injection, Novadaq's LUNA™ fluorescence angiography system will be utilized to map a standard skin perfusion image (SPI) over the upper extremities and anterior chest wall.<br>|
| Control Group<br>This group will consist of patients that serve as controls who do not have diagnosis of sepsis, severe sepsis, or septic shock. | Device: skin perfusion image<br>* Upon enrollment following written, informed consent, the patient will receive an injection of 7.5 mg of Indocyanine Green (ICG) intravenously (Dilute 25 mg of Indocyanine Green (ICG) with 10 cc of solvent to achieve a 2.5 mg/cc concentration.) Following injection, Novadaq's LUNA™ fluorescence angiography system will be utilized to map a standard skin perfusion image (SPI) over the upper extremities and anterior chest wall.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Perfusion Value | 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. | Up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoperfusion, Sepsis