A Feasibility Study on Ultrafiltration and Blood Volume Measurements

November 12, 2024 updated by: Nuwellis, Inc.
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Midwest Cardiovascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  11. Allergic to iodine, albumin, or iodinated I-131 albumin
  12. Active myocarditis or hypertrophic obstructive cardiomyopathy
  13. Severe uncorrected valvular stenosis
  14. Complex congenital heart disease
  15. Systemic infection
  16. Previous organ transplant
  17. Enrollment in other clinical trials
  18. Life expectancy ≤ 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single-arm
No comparator, placebo, or randomization
Device: Aquadex FlexFlow System and BVA-100
Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration
Time Frame: Through study procedure completion, average of 2 weeks
BVA will be used to evaluate changes in blood volume from baseline (i.e., before initiation) until completion of extracorporeal fluid removal by ultrafiltration.
Through study procedure completion, average of 2 weeks
2. Evaluate if changes in blood volume, as measured by BVA, correlate with changes in HCT as measured by the device embedded in the Aquadex FlexFlow System ultrafiltration device
Time Frame: Through study procedure completion, average of 2 weeks
A correlation between BVA measured change in blood volume to changes in hematocrit (HCT) as measured by the online HCT sensor embedded in the Aquadex Flexflow system will be determined.
Through study procedure completion, average of 2 weeks
3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload
Time Frame: Through study procedure completion, average of 2 weeks
Temporal relationship between blood volume change (as measured by the BVA) and changes in clinical signs and symptoms of fluid overload will be evaluated.
Through study procedure completion, average of 2 weeks
4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload
Time Frame: Through study procedure completion, average of 2 weeks
Temporal relationship between HCT change (as measured by Aquadex HCT sensor) and changes in clinical signs and symptoms of fluid overload will be evaluated.
Through study procedure completion, average of 2 weeks
5. Total net fluid loss prior to hospital discharge
Time Frame: Daily during study procedure, average of 2 weeks
The total net fluid removed during the ultrafiltration therapy will be evaluated.
Daily during study procedure, average of 2 weeks
6. Change in urinary sodium concentration from baseline to ultrafiltration completion
Time Frame: Through study procedure completion, average of 2 weeks
Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.
Through study procedure completion, average of 2 weeks
7. Change in biomarkers from baseline until discharge:
Time Frame: through study completion, average of 2 weeks
  • Comprehensive Metabolic Panel (CMP)/Basic Metabolic Panel (BMP)
  • N-terminal proB- type natriuretic peptide (NT-proBNP)
  • Troponin-I
  • Urine Nephrocheck
through study completion, average of 2 weeks
8. Adverse events of special interest
Time Frame: through study completion, average of 1 year
  • Acute coronary syndrome
  • Bleeding (requiring blood transfusion or drop of hemoglobin >3g/dl)
  • Catheter-related bloodstream infections
  • Hypotension necessitating intervention
through study completion, average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nuwellis, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daxor Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Rosa Costanzo, MD, Edward Hospital Center for Advanced Heart Failure
  • Principal Investigator: Maria Rosa Costanzo, MD, Edward-Elmhurst Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIN06477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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