Heart Failure Clinical Trial

Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

Summary

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.

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Full Description

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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Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of heart failure

>/= 2 criteria of volume overload

JVD > 7 cm
Ascites
Lower extremity edema
Sacral Edema
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

Study is for people with:

Heart Failure

Estimated Enrollment:

30

Study ID:

NCT00861770

Recruitment Status:

Completed

Sponsor:

Christiana Care Health Services

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There is 1 Location for this study

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Christiana Care Health Services
Newark Delaware, 19718, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

30

Study ID:

NCT00861770

Recruitment Status:

Completed

Sponsor:


Christiana Care Health Services

How clear is this clinincal trial information?

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