Denver Health Medical Center
Denver, Colorado, 80204, United States
NCT Number: NCT05101031
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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Notify Me18 year–99 year
All sexes
Observational
Denver, Colorado, 80204, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Primary Criteria
Secondary Criteria
Exclusion criteria
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.
Time frame: During fluid bolus
Change in stroke volume following the administration of each 500 cc fluid bolus.
Time frame: during fluid bolus
Concordance between change in stroke volume compared between fluid bolus and other usual care assessments of effective circulating volume
Time frame: 72 hours
Fluid balance inclusive of all parenteral fluids and all output
Time frame: Up to 180 days from ICU admission
Length of ICU stay (days) until subject is medically ready for discharge
Time frame: 28 days
Requirement for mechanical ventilation during hospitalization
Time frame: 28 days
Requirement for vasopressor use during hospitalization
Time frame: 28 days
Changes in serum creatinine levels from baseline
Time frame: 28 days
Requirement for renal replacement therapy (RRT)
Time frame: 28 days
Incidence of Major Adverse Cardiac Event (MACE)
Time frame: 28 days
Incident of Adverse Events
Time frame: 28 days
Inhospital Mortality rate
Time frame: Up to 180 days from hospital admission
Discharge location after hospitalization
Time frame: 28 days
Mean difference in fluid balance at ICU discharge
Ivor Douglas
Other
Acronym: Fresh-ER
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.