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

Study Overview

• Status: Completed
• Conditions: Undifferentated Shock
• Intervention / Treatment: Device: Starling SV

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from all patients who undergo present to the Emergency Room with symptoms of suspected or confirmed septic shock, and who are identified to receive a 30cc/kg fluid bolus of resuscitation fluid as part of treatment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Volume Change	Change in stroke volume following the administration of each 500 cc fluid bolus.	During fluid bolus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Volume Difference	Concordance between change in stroke volume compared between fluid bolus and other usual care assessments of effective circulating volume	during fluid bolus
Fluid Input and Output	Fluid balance inclusive of all parenteral fluids and all output	72 hours
LOS in ICU	Length of ICU stay (days) until subject is medically ready for discharge	Up to 180 days from ICU admission
Mechanical ventilation	Requirement for mechanical ventilation during hospitalization	28 days
Vasopressor Use	Requirement for vasopressor use during hospitalization	28 days
Serum Creatinine Levels	Changes in serum creatinine levels from baseline	28 days
Renal Replacement Therapy	Requirement for renal replacement therapy (RRT)	28 days
MACE	Incidence of Major Adverse Cardiac Event (MACE)	28 days
Adverse Events	Incident of Adverse Events	28 days
Mortality	Inhospital Mortality rate	28 days
Discharge Location	Discharge location after hospitalization	Up to 180 days from hospital admission
Fluid Input and Output in ICU	Mean difference in fluid balance at ICU discharge	28 days

Collaborators and Investigators

• Sponsor: Ivor Douglas
• Collaborators: Baxter Healthcare Corporation; Oregon Health and Science University
• Investigators: Principal Investigator: Ivor Douglas, MD, Denver Health Medical Center

Publications and helpful links

General Publications

• Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
• Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd.
• Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
• Kelm DJ, Perrin JT, Cartin-Ceba R, Gajic O, Schenck L, Kennedy CC. Fluid overload in patients with severe sepsis and septic shock treated with early goal-directed therapy is associated with increased acute need for fluid-related medical interventions and hospital death. Shock. 2015 Jan;43(1):68-73. doi: 10.1097/SHK.0000000000000268.
• Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.
• Vincent et al. Sepsis in European ICU: Results of the SOAP study. British Journal of Anesthesia 2006; 113: 740-747.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): December 17, 2022
• Study Completion (Actual): December 17, 2022

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Resuscitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 20-2845

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No