Daxor - Blood Volume Analysis

Duke University31 enrolled

Overview

The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.

The purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. Blood volume analysis (BVA) measures how much blood is in the investigator's arteries and veins and is performed by using an IV and injecting a small amount of a radioactive material (I 131-labeled albumin). The study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). There will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Failure Congestive Heart Failure

Interventions

Receive Blood Volume Analysis Guided TreatmentDEVICE

The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina Exclusion Criteria: * Age \< 18 years * Ongoing pregnancy * Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days * Post heart transplantation or ongoing mechanical circulatory support * Progressive cardiogenic shock * Patients with Ventricular Assist Devices * End stage renal disease

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in Whole Blood Volume

Time frame: Baseline, and upon discharge (up to day 18)

Secondary Outcomes

Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)

Comparison of baseline to follow up times

Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

Change in Mean NTpro-BNP Concentration (in pg/mL)

Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

Change in Weight (in kg)

Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

Change in Renal Function as Measured by Creatinine (mg/dL)

Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)

Comparison of baseline to follow up times

Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)

Comparison of baseline to follow up times

Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)

Data from ClinicalTrials.gov

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