Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- NYU Langone Health
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
Study Overview
Brief Summary
This is a prospective cohort study for 50 patients admitted to the cardiac care unit requiring clinically-indicated diuretic therapy for congestive heart failure. The purpose of this study is to assess the role of non-invasive cardiac output monitoring (NICOM) with the Starling Fluid Management System (Baxter Medical, Deerfield, IL) in determining volume status in patients with acute decompensated heart failure requiring intravenous diuretic therapy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis
- •Admission to coronary/cardiac intensive care unit or cardiac step down unit
- •Able to provide written informed consent
- •Anticipated need for IV diuretics > 24 hrs
Exclusion Criteria
- •Prisoner, pregnancy or post-partum stage, or age < 18 years
- •Known allergy to sensory material or gel
- •End stage renal disease or need for CRRT
- •Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation)
- •Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator
- •Inability to provide informed consent
Outcomes
Primary Outcomes
Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
Time Frame: Baseline, At Discharge (up to 1 week)
The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.
Secondary Outcomes
- Change in heart rate after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Output (CO) before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Output (CO) after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Stroke Volume Index (SVI) before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Index (CI) before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Index (CI) after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in heart rate before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Mean arterial pressure before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Mean arterial pressure after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Stroke Volume Index (SVI) after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))