Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure (CATAS-HF)
Primary Purpose
Heart Failure; With Decompensation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACE compression wrap
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure; With Decompensation focused on measuring Compression wraps, heart failure, systolic, edema, wrap
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
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Bilateral lower extremity ACE compression wraps in addition to standard medical care
Standard medical care
Outcomes
Primary Outcome Measures
Number of Participants With Readmission Within 30-days
Assess rate of 30-day readmission of patients enrolled in study
Total Length of Hospital Stay
Assess the length of hospitalization, controlling for variables
Days on IV Diuretic Therapy
Assess the number of days from start of IV diuresis to transition to PO diuresis
Secondary Outcome Measures
Average Percentage of BNP Change
Assess the average percent of BNP reduction of intervention vs control groups
Average Pre-discharge BNP
Assess the average pre-discharge BNP of intervention vs control groups
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
IV Diuretic Infusion Used
Assess the use of IV diuretic in intervention vs control groups
Average Percentage of Weight Change During Hospitalization
Assess the average percent of weight reduction of intervention vs control groups
AKI During Hospitalization
Development of acute kidney injury during hospitalization
Full Information
NCT ID
NCT04095416
First Posted
August 13, 2019
Last Updated
March 17, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT04095416
Brief Title
Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure
Acronym
CATAS-HF
Official Title
Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
challenges in recruitment due to covid-19
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
January 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure; With Decompensation
Keywords
Compression wraps, heart failure, systolic, edema, wrap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Bilateral lower extremity ACE compression wraps in addition to standard medical care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard medical care
Intervention Type
Device
Intervention Name(s)
ACE compression wrap
Intervention Description
Bilateral lower extremity ACE compression wraps
Primary Outcome Measure Information:
Title
Number of Participants With Readmission Within 30-days
Description
Assess rate of 30-day readmission of patients enrolled in study
Time Frame
30 days from hospital discharge
Title
Total Length of Hospital Stay
Description
Assess the length of hospitalization, controlling for variables
Time Frame
From admission to hospital discharge, up to 30 days
Title
Days on IV Diuretic Therapy
Description
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
Secondary Outcome Measure Information:
Title
Average Percentage of BNP Change
Description
Assess the average percent of BNP reduction of intervention vs control groups
Time Frame
From admission to hospital discharge, up to 30 days
Title
Average Pre-discharge BNP
Description
Assess the average pre-discharge BNP of intervention vs control groups
Time Frame
From admission to hospital discharge, up to 30 days
Title
Net Intake/Output of Fluids During Hospitalization
Description
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
Title
IV Diuretic Infusion Used
Description
Assess the use of IV diuretic in intervention vs control groups
Time Frame
From admission to hospital discharge, up to 30 days
Title
Average Percentage of Weight Change During Hospitalization
Description
Assess the average percent of weight reduction of intervention vs control groups
Time Frame
From admission to hospital discharge, up to 30 days
Title
AKI During Hospitalization
Description
Development of acute kidney injury during hospitalization
Time Frame
From admission to hospital discharge, up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure
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