Compression Wraps as Adjuvant Therapy in Management of Ac... | NCT04095416

Compression Wraps as Adjuvant Therapy in Management of Ac... | NCT04095416 | Trialant

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Bilateral lower extremity ACE compression wraps in addition to standard medical care	Device: ACE compression wrap
Control	No Intervention	Standard medical care

Name	Type	Description	Arm Group Labels	Other Names
ACE compression wrap	Device	Bilateral lower extremity ACE compression wraps	Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Hospital		Detroit	Michigan	48202	United States

Arm/Group Information

ID	Title	Description
FG000	Intervention	Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
FG001	Control	Standard medical care

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00119 subjects
COMPLETED		FG00010 subjects FG00119 subjects
NOT COMPLETED		FG0003 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Readmission Within 30-days

Assess rate of 30-day readmission of patients enrolled in study

Posted

Count of Participants

Participants

30 days from hospital discharge

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Raef Ali Fadel	Henry Ford Hospital	3139321347		rfadel2@hfhs.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 1, 2020	Feb 1, 2022	Prot_SAP_002.pdf
ICF	No	No	Yes	Informed Consent Form	Aug 1, 2019	Feb 1, 2022	ICF_003.pdf

Condition Browse Module

ID	Term
D006333	Heart Failure
D054160	Systolic Murmurs
D004487	Edema

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006337	Heart Murmurs
D012816	Signs and Symptoms

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0006 BG00112 BG00218
White	BG0004 BG0017 BG00211
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0000 BG0010 BG0020

Primary

Total Length of Hospital Stay

Assess the length of hospitalization, controlling for variables

Posted

Mean

Standard Deviation

days

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0004.6± 2.6 OG0017.4± 3.9

Primary

Days on IV Diuretic Therapy

Assess the number of days from start of IV diuresis to transition to PO diuresis

Posted

Mean

Standard Deviation

days

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0004.2± 3.1 OG0015.0± 1.8

Secondary

Average Percentage of BNP Change

Assess the average percent of BNP reduction of intervention vs control groups

Posted

Mean

Standard Deviation

% change

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG000-38.5± 22.8 OG001-38.2± 57.6

Secondary

Average Pre-discharge BNP

Assess the average pre-discharge BNP of intervention vs control groups

Posted

Mean

Standard Deviation

pg/mL

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0001404± 1441 OG0011238± 896

Secondary

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

Posted

Mean

Standard Deviation

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG000-8.13± 8.05 OG001-7.08± 6.21

Secondary

IV Diuretic Infusion Used

Assess the use of IV diuretic in intervention vs control groups

Posted

Count of Participants

Participants

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0017

Secondary

Average Percentage of Weight Change During Hospitalization

Assess the average percent of weight reduction of intervention vs control groups

Posted

Mean

Standard Deviation

% change

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG000-7.2± 6.1 OG001-5.7± 5.2

Secondary

AKI During Hospitalization

Development of acute kidney injury during hospitalization

Posted

Count of Participants

Participants

From admission to hospital discharge, up to 30 days

ID	Title	Description
OG000	Intervention	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team
OG001	Control	Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care

Units	Counts
Participants	OG00010 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0001 OG00113