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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| Baxter Healthcare Corporation | INDUSTRY |
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The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during rapid fluid bolus.
The Noninvasive Starling SV (Baxter Healthcare) is a portable, non-invasive, cardiac output detector system. The Starling SV system measures the cardiac output by employing electrical bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.
The objective of the study is observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration.
This study is a prospective feasibility study. Patients will be evaluated by the Emergency Room team for Inclusion/Exclusion criteria. If the patient is found to fit the study inclusion and exclusion criteria, then the fully non-invasive Starling monitor will be applied to the patient and the patient's hemodynamic data will be prospectively collected during the initial fluid resuscitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denver Health Medical Center | SV machine will be attached if hypotensive and in the emergency department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starling SV | Device | The Starling SV will monitor the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial fluid resuscitation in individuals with hypotension related to infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Volume Change | Change in stroke volume following the administration of each 500 cc fluid bolus. | During fluid bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Volume Difference | Concordance between change in stroke volume compared between fluid bolus and other usual care assessments of effective circulating volume | during fluid bolus |
| Fluid Input and Output |
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Inclusion Criteria:
Primary Criteria
MAP <65
SBP <90 or BP rapidly trending lower
Secondary Criteria
Low urine output Acute change in urine output less than 50ml/4 hours
Persistent hyperlactatemia
A new vasopressor started
Acute change in HR less than 50 or greater than 120
New onset chest pain or chest pain different then admission assessment
Acute bleeding
Fever > 39 degrees
Significant change in mental status: confusion, agitation, delirium, etc.
Unexplained lethargy
CRT >2 seconds -
Exclusion Criteria:
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The study population will be drawn from all patients who undergo present to the Emergency Room with symptoms of suspected or confirmed septic shock, and who are identified to receive a 30cc/kg fluid bolus of resuscitation fluid as part of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Ivor Douglas, MD | Denver Health Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18214429 | Background | Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23. | |
| 23774337 | Result | Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd. |
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Fluid balance inclusive of all parenteral fluids and all output
| 72 hours |
| LOS in ICU | Length of ICU stay (days) until subject is medically ready for discharge | Up to 180 days from ICU admission |
| Mechanical ventilation | Requirement for mechanical ventilation during hospitalization | 28 days |
| Vasopressor Use | Requirement for vasopressor use during hospitalization | 28 days |
| Serum Creatinine Levels | Changes in serum creatinine levels from baseline | 28 days |
| Renal Replacement Therapy | Requirement for renal replacement therapy (RRT) | 28 days |
| MACE | Incidence of Major Adverse Cardiac Event (MACE) | 28 days |
| Adverse Events | Incident of Adverse Events | 28 days |
| Mortality | Inhospital Mortality rate | 28 days |
| Discharge Location | Discharge location after hospitalization | Up to 180 days from hospital admission |
| Fluid Input and Output in ICU | Mean difference in fluid balance at ICU discharge | 28 days |
| 12065368 | Result | Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000. |
| 25247784 | Result | Kelm DJ, Perrin JT, Cartin-Ceba R, Gajic O, Schenck L, Kennedy CC. Fluid overload in patients with severe sepsis and septic shock treated with early goal-directed therapy is associated with increased acute need for fluid-related medical interventions and hospital death. Shock. 2015 Jan;43(1):68-73. doi: 10.1097/SHK.0000000000000268. |
| 20975548 | Result | Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15. |
| Result | Vincent et al. Sepsis in European ICU: Results of the SOAP study. British Journal of Anesthesia 2006; 113: 740-747. |