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

Not Applicable

Terminated

Conditions: Heart Failure; With Decompensation

Interventions: Device: ACE compression wrap

Registration Number: NCT04095416

Lead Sponsor: Henry Ford Health System

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 32

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	ACE compression wrap	Bilateral lower extremity ACE compression wraps in addition to standard medical care

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average Percentage of BNP Change	From admission to hospital discharge, up to 30 days	Assess the average percent of BNP reduction of intervention vs control groups
Net Intake/Output of Fluids During Hospitalization	From admission to hospital discharge, up to 30 days	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
Average Percentage of Weight Change During Hospitalization	From admission to hospital discharge, up to 30 days	Assess the average percent of weight reduction of intervention vs control groups
IV Diuretic Infusion Used	From admission to hospital discharge, up to 30 days	Assess the use of IV diuretic in intervention vs control groups
AKI During Hospitalization	From admission to hospital discharge, up to 30 days	Development of acute kidney injury during hospitalization
Average Pre-discharge BNP	From admission to hospital discharge, up to 30 days	Assess the average pre-discharge BNP of intervention vs control groups