Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Other: Ultrafiltration; Other: Ultrafiltration using BVM

• Registration Number: NCT00861770
• Lead Sponsor: Christiana Care Health Services

Brief 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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - Control	Ultrafiltration	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.
2 - BVM	Ultrafiltration using BVM	Ultrafiltration will be guided by blood volume measurement results.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States