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

Heart Failure; With Decompensation Clinical Trial

— CATAS-HF  

Official title:

Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04095416
• Other study ID #: CATASHFtrial2019
• Status: Terminated
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: March 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 21, 2021
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Heart Failure; With Decompensation
• Systolic Murmurs

Intervention

Device:
• ACE compression wrap
Bilateral lower extremity ACE compression wraps

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Readmission Within 30-days	Assess rate of 30-day readmission of patients enrolled in study	30 days from hospital discharge
Primary	Total Length of Hospital Stay	Assess the length of hospitalization, controlling for variables	From admission to hospital discharge, up to 30 days
Primary	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	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
Secondary	Average Pre-discharge BNP	Assess the average pre-discharge BNP of intervention vs control groups	From admission to hospital discharge, up to 30 days
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	From admission to hospital discharge, up to 30 days
Secondary	IV Diuretic Infusion Used	Assess the use of IV diuretic in intervention vs control groups	From admission to hospital discharge, up to 30 days
Secondary	Average Percentage of Weight Change During Hospitalization	Assess the average percent of weight reduction of intervention vs control groups	From admission to hospital discharge, up to 30 days
Secondary	AKI During Hospitalization	Development of acute kidney injury during hospitalization	From admission to hospital discharge, up to 30 days