NCT00861770

Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Christiana Care Health Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
OTHER	Ultrafiltration	Ultrafiltration based on standard of care.
OTHER	Ultrafiltration using BVM	Ultrafiltration will be guided by blood volume measurement results.

Timeline

• Start date: 2008-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2009-03-13
• Last updated: 2017-05-11

Locations

1 site across 1 country: United States