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A Feasibility Study on Ultrafiltration and Blood Volume Measurements | Clinical Trials | Clareo Health

TERMINATEDNA

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

NCT04241718•Nuwellis, Inc.

Summary

The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

Detailed Description

The study will measure blood volumes at various time intervals using the BVA-100 for comparison to corresponding readings of hematocrit (HCT) levels from the Aquadex FlexFlow HCT sensor. Establishing a correlation between BVA measurements (off-line measurements) and HCT sensor measurements (on-line measurements) may enable the use of the BVA-100 to guide ultrafiltration therapy by the Aquadex system for fluid removal. BVA-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while HCT measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with ADHF.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years or older
•2. Subject or legally authorized representative is able to provide appropriate consent to participate
•3. Hospitalized for ADHF with fluid overload as indicated by at least two of the following:
•1. Pitting edema ≥ 2+ of the lower extremities
•2. Jugular venous distention \> 8 cm
•3. Pulmonary edema/pleural effusion on chest x-ray
•4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
•5. Respiration rate ≥ 20 per minute

Exclusion Criteria

•1. Unable or unwillingness to provide informed consent or to comply with study requirements
•2. Subject who is pregnant
•3. Acute coronary syndrome
•4. Known bilateral renal artery stenosis
•5. Serum creatinine \> 3.0 mg/dL at the time of presentation
•6. Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
•7. Systolic blood pressure ≤ 90 mmHg
•8. Poor or unattainable central access
•9. Has bleeding disorder
•10. Contraindications to systemic anticoagulation
+8 more criteria

Locations (1)

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Key Dates

Start Date

December 19, 2019

Primary Completion Date

December 27, 2022

Completion Date

December 27, 2022

Last Updated

November 14, 2024

Enrollment

ACTUAL participants

Conditions

Acute Decompensated Heart FailureFluid Overload

Interventions

Aquadex FlexFlow System and BVA-100

DEVICE

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

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RECRUITING

Concordance and Discordance in the Assessment of Volume Status in Home Dialysis Patients: A Comparison of Modified Medical Research Council Dyspnea Scale, Physical Exam, and Point of Care Ultrasound (POCUS)

NCT07178470

Fluid OverloadPOCUS+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Concordance and Discordance in the Assessment of Volume Status in Home Dialysis Patients: A Comparison of Modified Medical Research Council Dyspnea Scale, Physical Exam, and Point of Care Ultrasound (POCUS)

Add-on Diuretics in Acute Decompensated Heart Failure

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure