Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00861770
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Daxor Corporation
Information provided by (Responsible Party):
Christiana Care Health Services

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Other: Ultrafiltration Other: Ultrafiltration using BVM Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
Study Start Date : November 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
1 - Control
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
Ultrafiltration based on standard of care.
Experimental: 2 - BVM
Ultrafiltration will be guided by blood volume measurement results.
 Other: Ultrafiltration using BVM
Ultrafiltration will be guided by blood volume measurement results.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. Change in serum creatinine ≥ 0.5 mg/dL. [ Time Frame: 30 and 90 days ]
  3. Symptomatic hypotension during ultrafiltration. [ Time Frame: 2 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861770


Locations
Layout table for location information
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Daxor Corporation
Investigators
Layout table for investigator information
Principal Investigator: Mitchell Saltzberg, MD, FACC Christiana Care Health Services
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00861770    
Other Study ID Numbers: CCC28158
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by Christiana Care Health Services:
Congestive Heart Failure
Ultrafiltration
Blood Volume Measurement
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases