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| Name | Class |
|---|---|
| Daxor Corporation | INDUSTRY |
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This will be a clinical test to determine if using blood volume measurements (BVM) to help guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart failure leads to improved outcomes.
Subjects will be randomized into two groups. In the control group, the treating physician will not see the blood volume measurement results. In the experimental group, the physician will be given the blood volume measurement results. Ultrafiltration is performed based on the results of blood volume measurement in the experimental group followed by repeat blood volume analysis after 30 minutes of the completion of ultrafiltration. Clinical and laboratory assessment as per the standard of care will be used to assess overall fluid status, and blood volume measurement results will be used as the assessment of intravascular fluid. These assessments will be used to determine a goal quantity of fluid to be removed. All subjects will return for a clinical assessment at 30 and 90 days and laboratory data will be drawn at that time to evaluate renal functional indices, electrolytes and blood volume measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Control | Other | All subjects will receive blood volume measurement immediately before and 30 minutes after ultrafiltration is completed. In the control group, the treating physician will not see the blood volume measurement results and treat according to standard of care. |
|
| 2 - BVM | Experimental | Ultrafiltration will be guided by blood volume measurement results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrafiltration | Other | Ultrafiltration based on standard of care. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if using blood volume measurement to help guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart failure leads to improved outcomes. | 90 days | |
| Change in serum creatinine ≥ 0.5 mg/dL. | 30 and 90 days | |
| Symptomatic hypotension during ultrafiltration. | 2 days |
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Inclusion Criteria:
Primary diagnosis of heart failure
>/= 2 criteria of volume overload
CKD 3 or worse renal function ClCR < 60 ml/min
HCT < 40%
Serum Albumin >/= 2.5 gm/dL
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Saltzberg, MD, FACC | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19718 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014462 | Ultrafiltration |
| ID | Term |
|---|---|
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
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| Ultrafiltration using BVM |
| Other |
Ultrafiltration will be guided by blood volume measurement results. |
|
| D008919 | Investigative Techniques |
| D055585 | Physical Phenomena |
| D055598 | Chemical Phenomena |