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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-12-17

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.

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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.

Conditions

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Undifferentated Shock

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Denver Health Medical Center

SV machine will be attached if hypotensive and in the emergency department

Starling SV

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Primary Criteria

1. MAP \<65
2. SBP \<90 or BP rapidly trending lower

Secondary Criteria
3. Low urine output Acute change in urine output less than 50ml/4 hours
4. Persistent hyperlactatemia
5. A new vasopressor started
6. Acute change in HR less than 50 or greater than 120
7. New onset chest pain or chest pain different then admission assessment
8. Acute bleeding
9. Fever \> 39 degrees
10. Significant change in mental status: confusion, agitation, delirium, etc.
11. Unexplained lethargy
12. CRT \>2 seconds -

Exclusion Criteria

1. 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
2. Known aortic insufficiency, or aortic abnormalities
3. Requires immediate surgery
4. Advanced directives restricting implementation of the resuscitation protocol
5. Known intraventricular heart defect, such as VSD or ASD
6. Prisoner
7. Pregnancy
8. Age \<18
9. Known allergy to sensor material or gel
10. Suspected intra-abdominal hypertension
11. Inability to obtain IV access
12. Patient should be excluded based on the opinion of the Clinician/Investigator
13. Patient has an unstable airway

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No