The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
Hierarchical composite/win-ratio
1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment
Time frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)
KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition
Time frame: initiation of randomized therapy through 72 hours following completion of randomized therapy
Net sodium loss
Time frame: per 24 hours at end of randomized therapy
Time to discharge readiness
Time from initiation of randomized therapy to when the participant becomes medically ready for discharge from a decompensated heart failure treatment standpoint
Time frame: through hospital discharge, an average of 5 days
Time on IV diuretic therapy
Time frame: randomization through hospital discharge, assessed up to 30 days
Net fluid loss
Fluid input subtracted from total urine output
Time frame: per 24 hours at end of randomized therapy
Weight loss
Time frame: per 24 hours at end of randomized therapy
CV mortality and cumulative HF rehospitalizations
Both types of events will be combined in a total "event rate" compared between groups
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University of California Irvine
Irvine, California, United States
RECRUITINGScripps Memorial Hospital
La Jolla, California, United States
NOT_YET_RECRUITINGUC Davis Medical Center
Sacramento, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGPiedmont Atlanta Hospital
Atlanta, Georgia, United States
RECRUITINGPiedmont Augusta Hospital
Augusta, Georgia, United States
RECRUITINGNortheast Georgia Medical Center
Gainesville, Georgia, United States
RECRUITINGAdvocate Christ Medical Center
Oak Lawn, Illinois, United States
NOT_YET_RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGUniversity of Louisville Hospital
Louisville, Kentucky, United States
NOT_YET_RECRUITING...and 43 more locations
Time frame: 90 days after hospital discharge
Length of stay
Time from initiation of randomized therapy to hospital discharge
Time frame: through hospital discharge, an average of 5 days
Hypotension defined as systolic blood pressure < 80 mmHg documented with two readings at least 30 minutes apart with symptoms (e.g., chest pain, dizziness) or <80 mmHg requiring an intervention including IV fluids or vasopressors.
Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy
Severe electrolyte abnormality
serum potassium \<3.0 mEq/L with ≥ 0.5 mEq/L decrease from initiation of randomized therapy, magnesium \<1.3 mEq/L with ≥0.5 mEq/L decrease from initiation of randomized therapy, or sodium \<125 mEq/L with ≥ 5.0 mEq/L decrease from initiation of randomized therapy
Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
Worsening heart failure requiring a higher level of HF therapy
Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
Tinnitus or hearing loss lasting more than 30 minutes
Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy