Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)

Conditions
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Undifferentated Shock

Intervention / Treatment
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* Device: Starling SV


Participation Criteria
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Eligibility Criteria
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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: Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics, major cardiac arrhythmia, drug overdose, or injury from burn or trauma Known aortic insufficiency, or aortic abnormalities Requires immediate surgery Advanced directives restricting implementation of the resuscitation protocol Known intraventricular heart defect, such as VSD or ASD Prisoner Pregnancy Age <18 Known allergy to sensor material or gel Suspected intra-abdominal hypertension Inability to obtain IV access Patient should be excluded based on the opinion of the Clinician/Investigator Patient has an unstable airway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Denver Health Medical Center<br>SV machine will be attached if hypotensive and in the emergency department | Device: Starling SV<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Volume Change | Change in stroke volume following the administration of each 500 cc fluid bolus. | During fluid bolus | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resuscitation