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 can more efficiently decongest ADHF patients in comparison to Control Therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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).
Eastern Shore Research Institute
Fairhope, Alabama, United States
University of California Irvine
Irvine, California, United States
Total Urine Sodium Output
Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Time frame: 24 hours post-treatment initiation
Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.
Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI \[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\], severe electrolyte abnormality (serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq), symptomatic hypotension or hypertensive emergency.
Time frame: End of treatment, 0-72 hours.
Net Fluid Loss
Difference in the amount of net fluid removed during primary treatment
Time frame: End of treatment, 0-72 hours
Time on IV Loop Diuretics
Time from initiation of IV loop diuretics to discontinuation of IV loop diuretics
Time frame: 0 hours (treatment initiation) through hospital discharge, up to 1-2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan, United States
St. Louis VA
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Duke University Hospital
Durham, North Carolina, United States
Cone Health
Greensboro, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
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The Lindner Research Center at Christ Hospital
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...and 6 more locations