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Completed

NCT Number: NCT05101031

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

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Starling SV

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.

Primary outcomes

  1. Stroke Volume Change

    Time frame: During fluid bolus

    Change in stroke volume following the administration of each 500 cc fluid bolus.

Secondary outcomes

  1. Stroke Volume Difference

    Time frame: during fluid bolus

    Concordance between change in stroke volume compared between fluid bolus and other usual care assessments of effective circulating volume

  2. Fluid Input and Output

    Time frame: 72 hours

    Fluid balance inclusive of all parenteral fluids and all output

  3. LOS in ICU

    Time frame: Up to 180 days from ICU admission

    Length of ICU stay (days) until subject is medically ready for discharge

  4. Mechanical ventilation

    Time frame: 28 days

    Requirement for mechanical ventilation during hospitalization

  5. Vasopressor Use

    Time frame: 28 days

    Requirement for vasopressor use during hospitalization

  6. Serum Creatinine Levels

    Time frame: 28 days

    Changes in serum creatinine levels from baseline

  7. Renal Replacement Therapy

    Time frame: 28 days

    Requirement for renal replacement therapy (RRT)

  8. MACE

    Time frame: 28 days

    Incidence of Major Adverse Cardiac Event (MACE)

  9. Adverse Events

    Time frame: 28 days

    Incident of Adverse Events

  10. Mortality

    Time frame: 28 days

    Inhospital Mortality rate

  11. Discharge Location

    Time frame: Up to 180 days from hospital admission

    Discharge location after hospitalization

  12. Fluid Input and Output in ICU

    Time frame: 28 days

    Mean difference in fluid balance at ICU discharge

Sponsors and collaborators

Lead sponsor

Ivor Douglas

Other

Collaborators

  • Baxter Healthcare Corporation
  • Oregon Health and Science University

Registry information

Acronym: Fresh-ER

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.