Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
There will be two populations in this study: control group, and intervention group. These groups will undergo propensity matching to account for confounders and minimize selection bias. 120 patients will be enrolled, 60 to each population. The objective of this study is: assess the utility of lower extremity compression wraps as adjuvant therapy in inpatient management of acute systolic heart failure The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP. The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained. Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower extremity compression wraps to inpatient management of acute systolic heart failure.

Detailed Description
-----------------
There will be two populations in this study: control group, and intervention group. 120 patients will be enrolled, 60 to group, randomized in 1:1 fashion. The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP. The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained. Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower extremity compression wraps to inpatient management of acute systolic heart failure.

Official Title
-----------------
Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)

Conditions
-----------------
Heart Failure; With Decompensation

Intervention / Treatment
-----------------
* Device: ACE compression wrap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age greater than 18 and less than 85 years of age admitted to I5 with Acute Systolic Heart Failure with an ejection fraction of less than 50% as determined by echocardiogram within 6 months requiring inpatient management with intravenous diuresis. diagnosis of acute systolic heart failure, of any underlying etiology at least 2+ pitting edema (or documented lower extremity pitting edema of at least moderate or significant severity) on primary assessment. Exclusion Criteria: cannot tolerate IV diuresis who cannot wear or tolerate lower extremity compression stockings or wraps ESRD peripheral neuropathy ejection fraction greater than 50% as evaluated by echocardiogram within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms, one interventional group and one control. Interventional group receives compression wraps and standard medical care, control group only receives standard medical care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Bilateral lower extremity ACE compression wraps in addition to standard medical care | Device: ACE compression wrap<br>* Bilateral lower extremity ACE compression wraps<br>|
| No Intervention: Control<br>Standard medical care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Readmission Within 30-days | Assess rate of 30-day readmission of patients enrolled in study | 30 days from hospital discharge | 
| Total Length of Hospital Stay | Assess the length of hospitalization, controlling for variables | From admission to hospital discharge, up to 30 days | 
| Days on IV Diuretic Therapy | Assess the number of days from start of IV diuresis to transition to PO diuresis | From admission to hospital discharge, up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Percentage of BNP Change | Assess the average percent of BNP reduction of intervention vs control groups | From admission to hospital discharge, up to 30 days | 
| Average Pre-discharge BNP | Assess the average pre-discharge BNP of intervention vs control groups | From admission to hospital discharge, up to 30 days | 
| Net Intake/Output of Fluids During Hospitalization | Assess the net intake/output across the hospitalization of intervention vs control groups, obtained through nursing documentation of fluid intake and output recorded daily during the hospitalization | From admission to hospital discharge, up to 30 days | 
| IV Diuretic Infusion Used | Assess the use of IV diuretic in intervention vs control groups | From admission to hospital discharge, up to 30 days | 
| Average Percentage of Weight Change During Hospitalization | Assess the average percent of weight reduction of intervention vs control groups | From admission to hospital discharge, up to 30 days | 
| AKI During Hospitalization | Development of acute kidney injury during hospitalization | From admission to hospital discharge, up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, Compression wraps, systolic, edema, wrap