Ultra-sound Assisted Management of Heart Failure (USA-HF)

The University of Texas System (UT)

Status: Withdrawn

Conditions: Heart Failure

Treatments: Diagnostic Test: Hand Held Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04376424

19-0276

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation.

Full description

The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. The use of hand carried ultrasound is expected to reduce hospital Length of stay, heart failure re-admission rates, emergency room visits and in hospital complications such as renal failure. The hypothesis tested is as follows:

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. New admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, CXR showing pulmonary vascular congestion/pulmonary edema, elevated NTproBNP, dyspnea Not secondary to infectious process (pneumonia).
2. Heart failure NYHA class III, IV
3. Age>=18 years old

Exclusion criteria

1. End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Ultra Sound Guided Therapy Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Hand Held Ultrasound

Conventional Therapy Group

No Intervention group

Description:

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.