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

May 9, 2017 updated by: Christiana Care Health Services

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
90 days
Change in serum creatinine ≥ 0.5 mg/dL.
Time Frame: 30 and 90 days
30 and 90 days
Symptomatic hypotension during ultrafiltration.
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Collaborators

Daxor Corporation

Investigators

  • Principal Investigator: Mitchell Saltzberg, MD, FACC, Christiana Care Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCC28158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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