Heart Failure; With Decompensation
Conditions
Keywords
Compression wraps, heart failure, systolic, edema, wrap
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.
Interventions
DEVICEACE compression wrap
Bilateral lower extremity ACE compression wraps
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IV Diuretic Infusion Used | From admission to hospital discharge, up to 30 days | Assess the use of IV diuretic in intervention vs control groups |
| 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 |
| AKI During Hospitalization | From admission to hospital discharge, up to 30 days | Development of acute kidney injury during 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 |
| Average Pre-discharge BNP | From admission to hospital discharge, up to 30 days | Assess the average pre-discharge BNP 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 |
Countries
United States
Participant flow
Pre-assignment details
Enrollment terminated early due to COVID-19 pandemic
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 19 |
| Total | 29 |
Baseline characteristics
| Characteristic | Total | Intervention | Control |
|---|---|---|---|
| Admission BNP | 2095 pg/mL STANDARD_DEVIATION 1391 | 2279 pg/mL STANDARD_DEVIATION 1613 | 1997 pg/mL STANDARD_DEVIATION 1296 |
| Admission weight | 93.7 kg STANDARD_DEVIATION 24.7 | 98.3 kg STANDARD_DEVIATION 30.9 | 91.2 kg STANDARD_DEVIATION 21.3 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 13 | 63 years STANDARD_DEVIATION 16 | 64 years STANDARD_DEVIATION 12 |
| Ejection fraction, baseline | 28 % STANDARD_DEVIATION 10 | 32 % STANDARD_DEVIATION 10 | 26 % STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 22 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 19 |
| other Total, other adverse events | 0 / 10 | 0 / 19 |
| serious Total, serious adverse events | 0 / 10 | 0 / 19 |
Outcome results
Primary
Days on IV Diuretic Therapy
Assess the number of days from start of IV diuresis to transition to PO diuresis
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Days on IV Diuretic Therapy | 4.2 days | Standard Deviation 3.1 |
| Control | Days on IV Diuretic Therapy | 5.0 days | Standard Deviation 1.8 |
Primary
Number of Participants With Readmission Within 30-days
Assess rate of 30-day readmission of patients enrolled in study
Time frame: 30 days from hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Readmission Within 30-days | 2 Participants |
| Control | Number of Participants With Readmission Within 30-days | 5 Participants |
Primary
Total Length of Hospital Stay
Assess the length of hospitalization, controlling for variables
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Total Length of Hospital Stay | 4.6 days | Standard Deviation 2.6 |
| Control | Total Length of Hospital Stay | 7.4 days | Standard Deviation 3.9 |
Secondary
AKI During Hospitalization
Development of acute kidney injury during hospitalization
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | AKI During Hospitalization | 1 Participants |
| Control | AKI During Hospitalization | 13 Participants |
Secondary
Average Percentage of BNP Change
Assess the average percent of BNP reduction of intervention vs control groups
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Average Percentage of BNP Change | -38.5 % change | Standard Deviation 22.8 |
| Control | Average Percentage of BNP Change | -38.2 % change | Standard Deviation 57.6 |
Secondary
Average Percentage of Weight Change During Hospitalization
Assess the average percent of weight reduction of intervention vs control groups
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Average Percentage of Weight Change During Hospitalization | -7.2 % change | Standard Deviation 6.1 |
| Control | Average Percentage of Weight Change During Hospitalization | -5.7 % change | Standard Deviation 5.2 |
Secondary
Average Pre-discharge BNP
Assess the average pre-discharge BNP of intervention vs control groups
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Average Pre-discharge BNP | 1404 pg/mL | Standard Deviation 1441 |
| Control | Average Pre-discharge BNP | 1238 pg/mL | Standard Deviation 896 |
Secondary
IV Diuretic Infusion Used
Assess the use of IV diuretic in intervention vs control groups
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | IV Diuretic Infusion Used | 0 Participants |
| Control | IV Diuretic Infusion Used | 7 Participants |
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
Time frame: From admission to hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Net Intake/Output of Fluids During Hospitalization | -8.13 L | Standard Deviation 8.05 |
| Control | Net Intake/Output of Fluids During Hospitalization | -7.08 L | Standard Deviation 6.21 |