Heart Failure
Conditions
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTHand Held Ultrasound
Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay (days) | Immediately after discharge | number of days from admission to discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participant readmitted for any reason within 30 days of discharge, and percentage of participant ( out of all participant in each group) readmitted in each group within 30 days of discharge. | One month after original discharge | assessment of readmission to hospital |
| percent change in GFR | One month after original discharge | amount of change in GFR |
| Number of participants readmitted for heart failure with 30 days of discharge, and percentage of participant out of all participants in each group readmitted in each group within 30 days | One month after discharge | Follow up telephone call after discharge |
| Time to readmission | assessed within 4 weeks from index admission (i.e. thirty days readmission) | time between original hospitalization and readmission |
| Number of right heart catheterization in each group and percentage of right heart catheterization in each group | One month after admission | document what procedures were done |
| hospitalization Cost | immediately after discharge of hospitalization | hospitalization cost measured for all hospitalization stay from admission to discharge for each participant |
Countries
United States
Outcome results
None listed