The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS 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 DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The Reprieve Decongestion Management System, or Reprieve DMS, 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.
Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).
University Medical Center Groningen
Groningen, Netherlands
Wroclaw Medical University
Wroclaw, Poland
Total sodium loss (in mmol of sodium) per 24 hours
Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).
Time frame: End of treatment, an average of 72 hours
Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.
Primary safety endpoint is positive if any of the following occurs in an individual participant: 1. Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) \[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\] 2. Severe electrolyte abnormality defined as serum potassium \<3.0 milliequivalent/liter (mEq/L), magnesium \<1.3 mEq/L, or sodium \<135 mEq 3. Symptomatic hypotension (systolic pressure \<80mmHg) or hypertensive (systolic pressure \>200 mmHg and/or diastolic pressure \>120 mmHg) emergency.
Time frame: Through study completion, an average of 90 days
Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours
Difference between volume of urine output and fluid input during primary treatment normalized to 24 hours.
Time frame: End of treatment, an average of 72 hours
Weight loss per 24 hours at end of randomized therapy
Total time on loop diuretics during primary treatment
Time frame: End of treatment, an average of 72 hours
Time on IV loop diuretic
Total time on loop diuretics from initiation of randomized therapy to last dose of IV loop diuretic administered for ADHF
Time frame: End of treatment, an average of 72 hours
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Number of participants with ≥ 0.3 mg/dL increase in serum creatinine
In hospital worsening renal function defined as ≥ 0.3 mg/dL increase in serum creatinine during randomized therapy.
Time frame: End of treatment, an average of 72 hours