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The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepsis Group | This group will consist of surgical intensive care patients with diagnosis of sepsis, severe sepsis, or septic shock. |
| |
| Control Group | This group will consist of patients that serve as controls who do not have diagnosis of sepsis, severe sepsis, or septic shock. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin perfusion image | Device | 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 LUNAâ„¢ fluorescence angiography system will be utilized to map a standard skin perfusion image (SPI) over the upper extremities and anterior chest wall. |
| 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 |
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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:
Hepatic dysfunction as evidenced by:
Control arm inclusion criteria:
Exclusion Criteria:
Sepsis arm exclusion criteria:
Control arm exclusion criteria:
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The study population will consist of patients who are 1) primarily assigned to the Division of General Surgery, Trauma, and Surgical Critical Care and 2) admitted to the surgical intensive care units will be screened for eligibility based on enrollment criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Pei, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |