Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Denver Health Medical Center SV machine will be attached if hypotensive and in the emergency department |
Device: Starling SV
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.
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Outcome Measures
Primary Outcome Measures
- Stroke Volume Change [During fluid bolus]
Change in stroke volume following the administration of each 500 cc fluid bolus.
Secondary Outcome Measures
- Stroke Volume Difference [during fluid bolus]
Concordance between change in stroke volume compared between fluid bolus and other usual care assessments of effective circulating volume
- Fluid Input and Output [72 hours]
Fluid balance inclusive of all parenteral fluids and all output
- LOS in ICU [Up to 180 days from ICU admission]
Length of ICU stay (days) until subject is medically ready for discharge
- Mechanical ventilation [28 days]
Requirement for mechanical ventilation during hospitalization
- Vasopressor Use [28 days]
Requirement for vasopressor use during hospitalization
- Serum Creatinine Levels [28 days]
Changes in serum creatinine levels from baseline
- Renal Replacement Therapy [28 days]
Requirement for renal replacement therapy (RRT)
- MACE [28 days]
Incidence of Major Adverse Cardiac Event (MACE)
- Adverse Events [28 days]
Incident of Adverse Events
- Mortality [28 days]
Inhospital Mortality rate
- Discharge Location [Up to 180 days from hospital admission]
Discharge location after hospitalization
- Fluid Input and Output in ICU [28 days]
Mean difference in fluid balance at ICU discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
Primary Criteria
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MAP <65
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SBP <90 or BP rapidly trending lower
Secondary Criteria
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Low urine output Acute change in urine output less than 50ml/4 hours
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Persistent hyperlactatemia
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A new vasopressor started
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Acute change in HR less than 50 or greater than 120
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New onset chest pain or chest pain different then admission assessment
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Acute bleeding
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Fever > 39 degrees
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Significant change in mental status: confusion, agitation, delirium, etc.
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Unexplained lethargy
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CRT >2 seconds -
Exclusion Criteria:
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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
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Known aortic insufficiency, or aortic abnormalities
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Requires immediate surgery
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Advanced directives restricting implementation of the resuscitation protocol
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Known intraventricular heart defect, such as VSD or ASD
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Prisoner
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Pregnancy
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Age <18
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Known allergy to sensor material or gel
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Suspected intra-abdominal hypertension
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Inability to obtain IV access
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Patient should be excluded based on the opinion of the Clinician/Investigator
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Patient has an unstable airway
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Denver Health Medical Center | Denver | Colorado | United States | 80204 |
Sponsors and Collaborators
- Ivor Douglas
- Oregon Health and Science University
- Baxter Healthcare Corporation
Investigators
- Principal Investigator: Ivor Douglas, MD, Denver Health Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 20-2845