Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00861770

Acronym

TEAM UF

Enrollment

Registered

2009-03-13

Start date

2008-11-30

Completion date

2014-03-31

Last updated

2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure, Ultrafiltration, Blood Volume Measurement

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.

Interventions

OTHERUltrafiltration

Ultrafiltration based on standard of care.

OTHERUltrafiltration using BVM

Ultrafiltration will be guided by blood volume measurement results.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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.	90 days
Change in serum creatinine ≥ 0.5 mg/dL.	30 and 90 days
Symptomatic hypotension during ultrafiltration.	2 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026