Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2021-11-30
2021-11-17
Brief Summary
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Detailed Description
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Null: The use of hand carried ultrasound in the management of heart failure patients did not change outcome.
Alternative: The use of hand carried ultrasound in the management of heart failure patients did change outcome.
The study endpoints are as follows:
1. A primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay.
2. The secondary endpoint will be 30 days re-admission following heart failure hospitalization, emergency room visits and in hospital complications such as renal failure.
This is a randomized controlled un-blinded study that poses very minimal risk because patients will only undergo an ultrasound measurement of Inferior vein cava (IVC) and internal jugular vein diameter and compressibility. Also, the society will benefit greatly with the prospect of reducing hospitalization and medical complications, optimizing healthcare delivery to heart failure patients, and reducing hospitalization cost. The results of this study/study procedure will only direct medical therapy that heart failure patients usually receive through routine care such as dose and frequency of diuresis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ultra Sound Guided Therapy Group
Hand carried ultrasound will be used in this group to measure IVCd, collapsibility along with internal jugular vein collapsibility. The results of the ultrasound will be unblinded to the treating team.
Hand Held Ultrasound
Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
Conventional Therapy Group
Conventional therapy will occur the use of hand carried ultrasound. The results will be blinded to the treating team. The managing team will analyze the data at the end of the study.
No interventions assigned to this group
Interventions
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Hand Held Ultrasound
Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
Eligibility Criteria
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Inclusion Criteria
2. Heart failure NYHA class III, IV
3. Age\>=18 years old
Exclusion Criteria
2. end stage Heart failure on chronic inotrope (example Milrinone)
3. Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
4. morbid obesity BMI \> 40
5. incarcerated patients (prison) TDC.
6. pregnant patients
7. Patients with dyspnea not mainly due to heart failure, ESRD patients, intubated patients
8. Aged less than 18 years.
18 Years
ALL
Yes
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Wissam Khalife, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical Branch Galveston
Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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19-0276
Identifier Type: -
Identifier Source: org_study_id