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

NCT04095416 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-29

Study results available
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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.

Conditions

  • Heart Failure; With Decompensation

Interventions

DEVICE

ACE compression wrap

Bilateral lower extremity ACE compression wraps

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2020-03-02
Completion
2021-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04095416 on ClinicalTrials.gov