Clinical trial NCT05240651: Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
Official title: Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Decompensated Heart Failure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Adults age \> 18
* Decompensated heart failure requiring clinically-indicated intravenous (IV) diuresis
* Admission to the cardiac care unit (CCU) or the step down unit (SDU)
* Ability to perform a passive leg raise (PLR)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
Secondary outcomes:
measure: Change in Stroke Volume Index (SVI) before passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in estimated Cardiac Output (CO) before passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in estimated Cardiac Output (CO) after passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in estimated Cardiac Index (CI) before passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in estimated Cardiac Index (CI) after passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in heart rate before passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in heart rate after passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in Mean arterial pressure before passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
measure: Change in Mean arterial pressure after passive leg raise (PLR)
timeFrame: Baseline, At Discharge (up to 1 week)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Carlos Alviar, MD
role: PRINCIPAL_INVESTIGATOR
References: