Clinical trial NCT04095416: Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure
Official title: Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure; With Decompensation
Keywords: Compression wraps
heart failure
systolic
edema
wrap
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Readmission Within 30-days
timeFrame: 30 days from hospital discharge
measure: Total Length of Hospital Stay
timeFrame: From admission to hospital discharge, up to 30 days
measure: Days on IV Diuretic Therapy
timeFrame: From admission to hospital discharge, up to 30 days
Secondary outcomes:
measure: Average Percentage of BNP Change
timeFrame: From admission to hospital discharge, up to 30 days
measure: Average Pre-discharge BNP
timeFrame: From admission to hospital discharge, up to 30 days
measure: Net Intake/Output of Fluids During Hospitalization
timeFrame: From admission to hospital discharge, up to 30 days
measure: IV Diuretic Infusion Used
timeFrame: From admission to hospital discharge, up to 30 days
measure: Average Percentage of Weight Change During Hospitalization
timeFrame: From admission to hospital discharge, up to 30 days
measure: AKI During Hospitalization
timeFrame: From admission to hospital discharge, up to 30 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References: