An observational study in Undifferentated Shock, sponsored by Ivor Douglas. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Ivor Douglas · Observational
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 50 is below the median of 84 across 294 observational studies indexed under Hypotension.
Browse Hypotension studies →This is the only study on the registry with Ivor Douglas as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Primary Criteria
SBP \<90 or BP rapidly trending lower
Secondary Criteria
Exclusion Criteria:
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.
Stroke Volume Change
Change in stroke volume following the administration of each 500 cc fluid bolus.
Time frame: During fluid bolus
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
Incidence of Major Adverse Cardiac Event (MACE)
Time frame: 28 days
Adverse Events
Incident of Adverse Events
Time frame: 28 days
Mortality
Inhospital Mortality rate
Time frame: 28 days
Discharge Location
Discharge location after hospitalization
Time frame: Up to 180 days from hospital admission
Fluid Input and Output in ICU
Mean difference in fluid balance at ICU discharge
Time frame: 28 days
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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