Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | November 2008 |
| End Date: | December 2013 |
| Contact: | Angela DiSabatino, RN, MS |
| Email: | adisabatino@christianacare.org |
| Phone: | 302-733-2658 |
Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
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.
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.
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.
Inclusion Criteria:
- Primary diagnosis of heart failure
- >/= 2 criteria of volume overload
1. JVD > 7 cm
2. Ascites
3. Lower extremity edema
4. Sacral Edema
5. Pleural effusion by clinical or radiologic criteria
- CKD 3 or worse renal function ClCR < 60 ml/min
- HCT < 40%
- Serum Albumin >/= 2.5 gm/dL
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