Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients

NCT ID: NCT00861770

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type OTHER

Ultrafiltration

Intervention Type OTHER

Ultrafiltration based on standard of care.

2 - BVM

Ultrafiltration will be guided by blood volume measurement results.

Group Type EXPERIMENTAL

Ultrafiltration using BVM

Intervention Type OTHER

Ultrafiltration will be guided by blood volume measurement results.

Interventions

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Ultrafiltration

Ultrafiltration based on standard of care.

Intervention Type OTHER

Ultrafiltration using BVM

Ultrafiltration will be guided by blood volume measurement results.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daxor Corporation

INDUSTRY

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Saltzberg, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health Services

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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CCC28158

Identifier Type: -

Identifier Source: org_study_id

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