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

Tracking Information
First Submitted Date  ICMJE March 11, 2009
First Posted Date  ICMJE March 13, 2009
Last Update Posted Date May 11, 2017
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • 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 ]
  • Change in serum creatinine ≥ 0.5 mg/dL. [ Time Frame: 30 and 90 days ]
  • Symptomatic hypotension during ultrafiltration. [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
Official Title  ICMJE Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE
  • Other: Ultrafiltration
    Ultrafiltration based on standard of care.
  • Other: Ultrafiltration using BVM
    Ultrafiltration will be guided by blood volume measurement results.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Ultrafiltration
  • Experimental: 2 - BVM
    Ultrafiltration will be guided by blood volume measurement results.
    Intervention: Other: Ultrafiltration using BVM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2009)
50
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00861770
Other Study ID Numbers  ICMJE CCC28158
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christiana Care Health Services
Study Sponsor  ICMJE Christiana Care Health Services
Collaborators  ICMJE Daxor Corporation
Investigators  ICMJE
Principal Investigator: Mitchell Saltzberg, MD, FACC Christiana Care Health Services
PRS Account Christiana Care Health Services
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP