Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Other: Ultrafiltration
* Other: Ultrafiltration using BVM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 - Control<br>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. | Other: Ultrafiltration<br>* Ultrafiltration based on standard of care.<br>|
| Experimental: 2 - BVM<br>Ultrafiltration will be guided by blood volume measurement results. | Other: Ultrafiltration using BVM<br>* Ultrafiltration will be guided by blood volume measurement results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Ultrafiltration, Blood Volume Measurement