A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Fluid Overload Clinical Trial

Official title:

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04241718
• Other study ID #: CLIN06477
• Status: Terminated
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: December 27, 2022

Study information

• Verified date: February 2023
• Source: Nuwellis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Fluid Overload
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Midwest Cardiovascular Institute	Naperville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Nuwellis, Inc.	Daxor Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration	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
Primary	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	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
Primary	3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload	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
Primary	4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload	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
Primary	5. Total net fluid loss prior to hospital discharge	The total net fluid removed during the ultrafiltration therapy will be evaluated.	Daily during study procedure, average of 2 weeks
Primary	6. Change in urinary sodium concentration from baseline to ultrafiltration completion	Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.	Through study procedure completion, average of 2 weeks
Primary	7. Change in biomarkers from baseline until discharge:	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
Primary	8. Adverse events of special interest	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