Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

Congestive Heart Failure Clinical Trial

— TEAM UF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861770
• Other study ID #: CCC28158
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: May 9, 2017
• Start date: November 2008
• Est. completion date: March 2014

Study information

• Verified date: May 2017
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• Ultrafiltration
Ultrafiltration based on standard of care.
• Ultrafiltration using BVM
Ultrafiltration will be guided by blood volume measurement results.

Locations

Country	Name	City	State
United States	Christiana Care Health Services	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	Daxor Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in serum creatinine = 0.5 mg/dL.		30 and 90 days
Primary	Symptomatic hypotension during ultrafiltration.		2 days