A Feasibility Study on Ultrafiltration and Blood Volume Measurements

NCT ID: NCT04241718

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-12-27

Brief 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.

Conditions

Acute Decompensated Heart Failure; Fluid Overload

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single-arm

No comparator, placebo, or randomization

Group Type: OTHER

Aquadex FlexFlow System and BVA-100

Intervention Type: DEVICE

Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

Interventions

Aquadex FlexFlow System and BVA-100

Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daxor Corporation

INDUSTRY

Sponsor Role: collaborator

Nuwellis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Rosa Costanzo, MD

Role: PRINCIPAL_INVESTIGATOR

Edward Hospital Center for Advanced Heart Failure

Maria Rosa Costanzo, MD

Role: PRINCIPAL_INVESTIGATOR

Edward-Elmhurst Health System

Locations

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Countries

United States

Other Identifiers

CLIN06477

Identifier Type: -

Identifier Source: org_study_id