Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure

Acute Decompensated Heart Failure Clinical Trial

Official title:

Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240651
• Other study ID #: 20-02048
• Status: Recruiting
• Start date: August 30, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: Carlos Alviar, MD
• Phone: 212-263-6635
• Email: carlos.alviar[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis

2. Admission to coronary/cardiac intensive care unit or cardiac step down unit

3. Able to provide written informed consent

4. Anticipated need for IV diuretics > 24 hrs

Exclusion Criteria:

1. Prisoner, pregnancy or post-partum stage, or age < 18 years

2. Known allergy to sensory material or gel

3. End stage renal disease or need for CRRT

4. Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation)

5. Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator

6. Inability to provide informed consent

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)	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.	Baseline, At Discharge (up to 1 week)
Secondary	Change in Stroke Volume Index (SVI) before passive leg raise (PLR)	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.	Baseline, At Discharge (up to 1 week)
Secondary	Change in Stroke Volume Index (SVI) after passive leg raise (PLR)	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.	Baseline, At Discharge (up to 1 week)
Secondary	Change in estimated Cardiac Output (CO) before passive leg raise (PLR)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CO. 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 CO.	Baseline, At Discharge (up to 1 week)
Secondary	Change in estimated Cardiac Output (CO) after passive leg raise (PLR)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CO. 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 CO.	Baseline, At Discharge (up to 1 week)
Secondary	Change in estimated Cardiac Index (CI) before passive leg raise (PLR)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CI. 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 CI.	Baseline, At Discharge (up to 1 week)
Secondary	Change in estimated Cardiac Index (CI) after passive leg raise (PLR)	The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CI. 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 CI.	Baseline, At Discharge (up to 1 week)
Secondary	Change in heart rate before passive leg raise (PLR)		Baseline, At Discharge (up to 1 week)
Secondary	Change in heart rate after passive leg raise (PLR)		Baseline, At Discharge (up to 1 week)
Secondary	Change in Mean arterial pressure before passive leg raise (PLR)		Baseline, At Discharge (up to 1 week)
Secondary	Change in Mean arterial pressure after passive leg raise (PLR)		Baseline, At Discharge (up to 1 week)