NCT05240651 - Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure | Crick

Overview

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 Type

OBSERVATIONAL

Enrollment

50

Conditions

Acute Decompensated Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline, At Discharge (up to 1 week)

Secondary Outcomes

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.

Time frame: Baseline, At Discharge (up to 1 week)

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.

Time frame: Baseline, At Discharge (up to 1 week)

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.

Time frame: Baseline, At Discharge (up to 1 week)

Change in estimated Cardiac Output (CO) after passive leg raise (PLR)

Central Contacts

Carlos Alviar, MD

CONTACT

212-263-6635 carlos.alviar@nyulangone.org