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| Name | Class |
|---|---|
| Hutchinson Technology Inc | INDUSTRY |
| Astute Medical, Inc. | INDUSTRY |
| Axis Shield Diagnostics Ltd | INDUSTRY |
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The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.
Near-infrared spectroscopy (NIRS) noninvasively measures peripheral tissue oxygen saturation (StO2), offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving.
There are three main NIRS measurements reported in the literature: continuous StO2 measurement (StO2 initial), StO2 occlusion slope (StO2 downslope) in response to VOT testing and StO2 recovery slope (StO2 upslope) in response to vasoocclusive testing. The purpose of this study is to assesses the association of each of these parameters with severity of illness, organ dysfunction and death.
This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shock Cohort | The SHOCK cohort will meet the American College of Chest physicians/Society of Critical Care Medicine criteria for septic shock, specifically:
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| Sepsis cohort | The SEPSIS cohort will to meet:
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| Non-Infected controls | The third cohort will be comprised of uninfected ED control patients who met the criteria of no suspected infection, no SIRS criteria met and no evidence of hypoperfusion that are age and sex matched on a 1:1 basis with the shock cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared spectroscopy assessment | Diagnostic Test | The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements. Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Organ Dysfunction and Severity of Illness | time 0 - 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | In hospital |
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There will be three cohorts enrolled in this study: (1) Septic Shock, (2) Sepsis and (3) Controls.
Inclusion Criteria:
Listed on the Cohorts description.
Exclusion Criteria:
All patient cohorts will share common set of exclusion criteria:
Age < 18 years
Pregnancy
Established "Do Not Resuscitate" orders prior to enrollment
Primary diagnosis of:
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Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.
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| Name | Affiliation | Role |
|---|---|---|
| Nathan I Shapiro, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23824446 | Result | Skibsted S, Arnold R, Sherwin R, Singh S, Lundy D, Nelson T, Puskarich MA, Trzeciak S, Jones AE, Shapiro NI. The association of near infrared spectroscopy-derived StO2 measurements and biomarkers of endothelial activation in sepsis. Intern Emerg Med. 2013 Sep;8(6):529-36. doi: 10.1007/s11739-013-0973-3. Epub 2013 Jul 4. | |
| 21939529 |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Whole blood, serum
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| Shapiro NI, Arnold R, Sherwin R, O'Connor J, Najarro G, Singh S, Lundy D, Nelson T, Trzeciak SW, Jones AE; Emergency Medicine Shock Research Network (EMShockNet). The association of near-infrared spectroscopy-derived tissue oxygenation measurements with sepsis syndromes, organ dysfunction and mortality in emergency department patients with sepsis. Crit Care. 2011;15(5):R223. doi: 10.1186/cc10463. Epub 2011 Sep 22. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |