30
Participants
Start Date
August 17, 2023
Primary Completion Date
July 10, 2025
Study Completion Date
December 31, 2025
Furosemide (plus potassium chloride)
Furosemide is a loop diuretic that inhibits the reabsorption of sodium and chloride in the proximal and distal tubules as well as the loop of Henle. Participants will receive 2 mg/kg enteral furosemide daily during treatment periods when they receive study drug. To prevent hypokalemia and hypochloremia associated with furosemide use, participants will also receive 1 mg/kg of potassium chloride enterally twice per day when receiving furosemide. Each patient will have 8 days of total exposure to furosemide over the 16-day N-of-1 trial.
Placebo (plus placebo electrolyte solution)
During treatment periods when participants receive placebo, they will receive a volume of sterile water equivalent to the study drug dose. Participants will also receive a placebo electrolyte solution equivalent to the volume of potassium chloride that would be given.
RTI International, Durham
Emory University, Atlanta
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland
Cincinnati Children's Hospital Medical Center, Cincinnati
Rainbow Babies and Children's Hospital
OTHER
Emory University
OTHER
RTI International
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER