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The purpose of this study is to determine whether additional investigations used in other parts of healthcare can be used in the Emergency Department to identify critically ill patients quicker than usual care.
The investigators intend to recruit 56 patients with suspected sepsis who attend the Emergency Department. The investigators want to use a device to monitor tissue oxygen levels when they first come into the Emergency Department as well as the change in tissue oxygen levels when a tourniquet is applied for 3 minutes. The investigators will take novel blood tests when the patient is having their routine bloods. Finally, the investigators will use a special camera to take specialised pictures of the small blood vessels under the tongue which will show blood flow through these vessels. The investigators will follow the recruited patients and determine if our extra data is better at determining who needs critical care. A significant proportion of patients may be too unwell or too distressed to consent to be part of this study. At the earliest opportunity, the investigators will ask patients when they have been stabilised and are able to give consent. If they say no, they will be removed from the study and their care will not be affected by this decision.
The results could help us identify septic shock as early as possible so that these unwell patients are identified early and get the correct treatment they need. This could mean starting advanced treatments usually found in the Intensive Care Unit very early on in a patient's journey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients presenting to the Emergency Department with suspected sepsis | Patients who present with potential sepsis. This is characterised by their illness suspected to be from an infection and significantly unwell defined by one of two scoring systems, either the National Early Warning Score or quick Sequential Organ Failure Assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measuring tissue oxygenation | Diagnostic Test | Measuring oxygen content of arteries, capillaries and veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in tissue oxygenation | The difference in tissue oxygen saturation (StO2) during the vascular occlusion test in the Emergency Department between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured in % change per second.. | Up to 4 hours (from baseline); 28 days (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline of tissue oxygenation | The difference in tissue oxygen saturation (StO2) at baseline in the Emergency Department between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured in %. | Up to 4 hours (from baseline); 28 days (follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
Traumatic injury
Rockwood frailty score ≥6
Critical care therapy previously believed to not be in patient's best interests
Critical care therapies-initiated pre-hospital. Critical care therapies defined as:
4.1 Mechanical ventilation 4.2 Vasopressor/inotrope therapy 4.3 Sedation or a general anaesthetic 4.4 Pre-hospital transfusion of blood products 4.5 Extra-corporeal support
Advanced directive refusing critical care therapies.
Acute cardiac failure
Active gastrointestinal bleed
Massive pulmonary embolism
ICU admission declined by critical care team
Treated in an acute hospital <6 hours before presentation to the Emergency Department
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Adult patients presenting to the Emergency Department with their illness possibly caused by sepsis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James N Ward, BM | Contact | +447881967336 | wardj@doctors.org.uk | |
| Ahilanandan Dushianthan, PhD | Contact | +447903943418 | a.dushianthan@soton.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ahilanandan Dushianthan, PhD | University Hospital Southampton NHS Foundation Trust | Study Director |
| James N Ward, BM | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30772908 | Background | Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Cavalcanti AB, Bakker J, Hernandez G, Alegria L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavez N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, Gonzalez H, Arancibia JM, Munoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Munoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpan B, Fasce F, Luengo C, Medel N, Cortes C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, Gonzalez MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudin A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, Garcia F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garces P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Perez V, Delgado G, Lopez A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderon A, Paredes G, Barberan JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernan Portilla A, Davila H, Mora JA, Calderon LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071. |
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Individual participant data (IPD) that underlie results in a publication will be shared
6 months after publication
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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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Twenty millilitres of whole blood will be collected. Plasma will be separated by centrifugation and stored at -80 degrees celsius until further analysis
| Procalcitonin | Diagnostic Test | Blood test |
|
|
| Mid-regional proadrenomedullin | Diagnostic Test | Blood test looking at inflammation in the body |
|
|
| Hand-held video microscope | Diagnostic Test | A handheld video microscope that looks at blood flow through the capillaries of the tongue |
|
| Difference in blood flow of the micro-circulation (microvascular flow index) |
Differences in the flow of blood through small blood vessels underneath the tongue between the difference between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured by the Microvascular Flow Index (arbitrary units) which is a validated measurement assessing micro-circulatory flow. |
| Up to 4 hours (from baseline); 28 days (follow-up) |
| Difference in blood flow of the micro-circulation (perfused vessel density) | Differences in the flow of blood through small blood vessels underneath the tongue between the difference between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured by the perfused vessel density (measured in mm/mm2) which is a validated measurement assessing micro-circulatory flow. | Up to 4 hours (from baseline); 28 days (follow-up) |
| Difference in blood lactate levels | The difference in the blood tests of lactate between septic patients who need critical care treatment (CCT) compared to patients requiring ward care | Up to 4 hours (from baseline); 28 days (follow-up) |
| Difference in blood tests (MR-proADM) | The difference in the blood tests of MR-proADM between septic patients who need critical care treatment (CCT) compared to patients requiring ward care | Up to 4 hours (from baseline); 28 days (follow-up) |
| Difference in blood tests (Procalcitonin) | The difference in the blood tests of Procalcitonin (PCT) between septic patients who need critical care treatment (CCT) compared to patients requiring ward care | Up to 4 hours (from baseline); 28 days (follow-up) |
| Correlation of extra investigations with standard patient outcomes | Looking at whether tissue oxygenation, buccal microcirculation (blood flow under the tongue) and biomarkers and correlation with clinical outcomes such as organ failure (SOFA) scores, 28-day hospital mortality, and length of hospital and ICU stay. | Up to 4 hours (from baseline); 28 days (follow-up) |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |