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

Completed

• Conditions: Undifferentated Shock

• Registration Number: NCT05101031
• Lead Sponsor: Ivor Douglas

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.

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 Timeline

• Study Start: 2020-12-18
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-10-29
• Primary Completion: 2022-12-17
• Study Completion: 2022-12-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke Volume Change	During fluid bolus	Change in stroke volume following the administration of each 500 cc fluid bolus.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	28 days	Incident of Adverse Events
MACE	28 days	Incidence of Major Adverse Cardiac Event (MACE)
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
Mortality	28 days	Inhospital Mortality rate
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
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
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)

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States