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

Ivor Douglas

Status: Completed

Conditions: Undifferentated Shock

Treatments: Device: Starling SV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05101031

20-2845

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Denver Health Medical Center

Description:

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

Treatment:

Device: Starling SV