Skip to main content
OpenTrials
Completed

NCT Number: NCT00861770

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Services

Newark, Delaware, 19718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrafiltration

Other

Ultrafiltration based on standard of care.

Ultrafiltration using BVM

Other

Ultrafiltration will be guided by blood volume measurement results.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Daxor Corporation

Registry information

Official study title

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

Acronym: TEAM UF

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2009
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.