Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
TEAM UF
Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 11, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 11, 2017
May 1, 2017
5.3 years
March 11, 2009
May 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
1 - Control
OTHERAll 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.
2 - BVM
EXPERIMENTALUltrafiltration will be guided by blood volume measurement results.
Interventions
Ultrafiltration will be guided by blood volume measurement results.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christiana Care Health Serviceslead
- Daxor Corporationcollaborator
Study Sites (1)
Christiana Care Health Services
Newark, Delaware, 19718, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Saltzberg, MD, FACC
Christiana Care Health Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2009
First Posted
March 13, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 11, 2017
Record last verified: 2017-05