A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Nuwellis

Status: Terminated

Conditions: Acute Decompensated Heart Failure; Fluid Overload

Treatments: Device: Aquadex FlexFlow System and BVA-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT04241718

CLIN06477

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Single-arm

Other group

Description:

No comparator, placebo, or randomization

Treatment:

Device: Aquadex FlexFlow System and BVA-100