Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure: A Cluster-Randomized Crossover Non-Inferiority Trial
University of Texas Southwestern Medical Center
Summary
This will be a prospective, cluster-randomized, crossover, non-inferiority trial of 250 participants within 48 hours of an inpatient admission for heart failure or emergency department presentation for heart failure with plans for admission or observation/short-stay hospitalization comparing early discharge using subcutaneous furosemide to standard inpatient care. Individual practice groups will serve as "clusters" and the unit of randomization. Each participating cluster will implement either the early discharge strategy using the intervention or standard care for initial two-month blocks, followed by a crossover to the alternate strategy. The primary outcome is days alive and out of hospital at 30 days.
Description
HF contributes to over 1 million emergency department visits and nearly 1 million hospitalizations annually. The estimated annual mean cost per person with HF was $32,955 in 2017-2018, with the majority of costs due to hospitalization. The current standard of care typically involves admission for intravenous (IV) diuretics, monitoring for adequate decongestion, transition to oral diuretics, and discharge once clinical stability is achieved. The median length of stay for HF hospitalizations in the United States is 5 days but varies significantly across health systems and at the patient level. E…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Within 48 hours of inpatient stay OR ED presentation for HF with plans for admission OR observation stay/short-stay hospitalization for HF * Expected to require at least 24 additional hours of IV diuretics * Adequate home environment for self-care * Patient or caregiver capable of operating subcutaneous delivery device Exclusion Criteria: * Cognitive impairment preventing informed consent * Geographic barriers to follow-up * Pregnancy or breastfeeding * IV furosemide requirement \>250mg/day * eGFR \<20 mL/min/1.73m2 * Type 1 myocardial infarction durin…
Interventions
- Combination ProductEarly Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor
Each practice group randomized to early discharge with subcutaneous furosemide will provide the patient with prefilled units of Lasix® ONYU furosemide injection containing 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor that will be used in conjunction with the reusable unit of the Lasix ONYU Infusor. Dosing based on pre-admission oral furosemide requirements: ≤80mg/day oral furosemide will be given 80mg subcutaneous once daily or \>80mg/day oral furosemide will be given 80mg subcutaneous twice daily. Dosing will be continued until clinical euvolemia is reached.
Locations (2)
- University of Texas Southwestern Medical CenterDallas, Texas
- Baylor Scott and White Health SystemDallas, Texas