Creating a Platform for Point-of-Care Pragmatic Clinical Trials: Comparing Diuretic Strategies in Heart Failure
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Stanford University
- Locations
- 1
- Primary Endpoint
- Hospital length of stay
Study Overview
Brief Summary
We will conduct a pragmatic randomized trial comparing whether using a combination of two types of diuretics (loop + thiazide) compared with using a single diuretic (loop only) will result in shorter hospital stays for patients hospitalized with heart failure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any adult (age ≥18 years) admitted to the Heart Failure Service at Stanford Health Care with an indication for treatment with a diuretic.
Exclusion Criteria
- •admission to the intensive care unit or cardiac care units
- •maintenance dialysis on admission
- •any mechanical circulatory support on admission
- •history of heart transplant
- •allergy / intolerance to loop or thiazide diuretics
- •admission serum sodium < 125 meq/L (from EPIC)
- •admission serum potassium < 3.0 meq/L (from EPIC)
Arms & Interventions
Loop only
Participants will receive a loop diuretic for up to the first 72 hours of hospitalization. The specific drug, dose and route are left to the treating providers.
Intervention: Loop Diuretics vs. loop + thiazide diuretics (Drug)
Loop + Thiazide
Participants will receive a loop+thiazide diuretic for up to the first 72 hours of hospitalization. The specific drugs, doses and routes are left to the treating providers.
Intervention: Loop Diuretics vs. loop + thiazide diuretics (Drug)
Outcomes
Primary Outcomes
Hospital length of stay
Time Frame: During hospitalization up to 90 days
Secondary Outcomes
- Composite of all-cause rehospitalizations, emergency department visits, or death in the 30 days after hospital discharge.(30 days)
Investigators
Tara I-Hsin Chang
Associate Professor of Medicine (Nephrology)
Stanford University