Clinical trial NCT04241718: A Feasibility Study on Ultrafiltration and Blood Volume Measurements
Official title: A Feasibility Study on Ultrafiltration and Blood Volume Measurements
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Fluid Overload
Lead sponsor: Nuwellis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Daxor Corporation
First posted: 2020-01-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration
timeFrame: Through study procedure completion, average of 2 weeks
measure: 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
timeFrame: Through study procedure completion, average of 2 weeks
measure: 3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload
timeFrame: Through study procedure completion, average of 2 weeks
measure: 4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload
timeFrame: Through study procedure completion, average of 2 weeks
measure: 5. Total net fluid loss prior to hospital discharge
timeFrame: Daily during study procedure, average of 2 weeks
measure: 6. Change in urinary sodium concentration from baseline to ultrafiltration completion
timeFrame: Through study procedure completion, average of 2 weeks
measure: 7. Change in biomarkers from baseline until discharge:
timeFrame: through study completion, average of 2 weeks
measure: 8. Adverse events of special interest
timeFrame: through study completion, average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Midwest Cardiovascular Institute
state: Illinois
Study officials:
affiliation: Edward Hospital Center for Advanced Heart Failure
name: Maria Rosa Costanzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edward-Elmhurst Health System
name: Maria Rosa Costanzo, MD
role: PRINCIPAL_INVESTIGATOR
References: