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Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients (TEAM UF)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrafiltration
Ultrafiltration using BVM
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Ultrafiltration, Blood Volume Measurement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christiana Care Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

1 - Control

2 - BVM

Arm Description

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.

Ultrafiltration will be guided by blood volume measurement results.

Outcomes

Primary Outcome Measures

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.
Change in serum creatinine ≥ 0.5 mg/dL.
Symptomatic hypotension during ultrafiltration.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2009
Last Updated
May 9, 2017
Sponsor
Christiana Care Health Services
Collaborators
Daxor Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00861770
Brief Title
Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
Acronym
TEAM UF
Official Title
Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
Collaborators
Daxor Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, Ultrafiltration, Blood Volume Measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Control
Arm Type
Other
Arm Description
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.
Arm Title
2 - BVM
Arm Type
Experimental
Arm Description
Ultrafiltration will be guided by blood volume measurement results.
Intervention Type
Other
Intervention Name(s)
Ultrafiltration
Intervention Description
Ultrafiltration based on standard of care.
Intervention Type
Other
Intervention Name(s)
Ultrafiltration using BVM
Intervention Description
Ultrafiltration will be guided by blood volume measurement results.
Primary Outcome Measure Information:
Title
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.
Time Frame
90 days
Title
Change in serum creatinine ≥ 0.5 mg/dL.
Time Frame
30 and 90 days
Title
Symptomatic hypotension during ultrafiltration.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Saltzberg, MD, FACC
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

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