About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Cognitive impairment preventing informed consent
Geographic barriers to follow-up
Pregnancy or breastfeeding
IV furosemide requirement >250mg/day
Trial design
Treatments tested in this trial
- Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor