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

Ivor Douglas50 enrolled

Overview

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.

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

Conditions

Undifferentated Shock

Interventions

Starling SVDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Denver Health Medical Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Stroke Volume Change

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

Time frame: During fluid bolus

Secondary Outcomes

Stroke Volume Difference

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

Time frame: during fluid bolus

Fluid Input and Output

Fluid balance inclusive of all parenteral fluids and all output

Time frame: 72 hours

LOS in ICU

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

Time frame: Up to 180 days from ICU admission

Mechanical ventilation

Requirement for mechanical ventilation during hospitalization

Time frame: 28 days

Vasopressor Use

Requirement for vasopressor use during hospitalization

Time frame: 28 days

Serum Creatinine Levels

Changes in serum creatinine levels from baseline

Time frame: 28 days

Renal Replacement Therapy

Requirement for renal replacement therapy (RRT)

Time frame: 28 days

MACE

Data from ClinicalTrials.gov

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