Ultra-sound Assisted Management of Heart Failure

Not Applicable

Withdrawn

• Conditions: Heart Failure
• Interventions: Diagnostic Test: Hand Held Ultrasound

• Registration Number: NCT04376424
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Status Verified: 2021-07
• Study Start: 2021-11
• Primary Completion: 2021-11
• Study Completion: 2021-11-17
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultra Sound Guided Therapy Group	Hand Held Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
length of hospital stay (days)	Immediately after discharge	number of days from admission to discharge

Secondary Outcome Measures

Name	Time	Method
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
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
hospitalization Cost	immediately after discharge of hospitalization	hospitalization cost measured for all hospitalization stay from admission to discharge for each participant
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

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States