Furosemide and Albumin for Diuresis of Edema (FADE): A parallel-group, blinded, pilot randomized controlled trial

Division of Critical Care Medicine, Department of Medicine, McMaster University, Canada; Department of Critical Care, Hamilton Health Sciences, Canada. Electronic address: oczkowsj@mcmaster.ca. Department of Critical Care, Hamilton Health Sciences, Canada. Schulich School of Medicine and Dentistry, Western University, Canada. Department of Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates. Department of Health Sciences Honours, Faculty of Health Sciences, McMaster University, Canada. Department of Health Research Methods, Evidence, and Impact, McMaster University, Canada; Biostatistics Unit, The Research Institute, St. Joseph's Healthcare, Hamilton, Canada. Division of Critical Care Medicine, Department of Medicine, McMaster University, Canada; Department of Critical Care, Hamilton Health Sciences, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Canada. Division of Critical Care Medicine, Department of Medicine, McMaster University, Canada; Department of Critical Care, Hamilton Health Sciences, Canada.

Journal of Critical Care. 2018;48:462-467
Abstract
PURPOSE To assess the feasibility of a trial evaluating whether hyperoncotic albumin, in addition to diuretics, improves diuresis and facilitates liberation from mechanical ventilation in critically ill adults. MATERIALS AND METHODS We randomized 46 hemodynamically stable patients with hypoalbuminemia, prescribed diuretics by treating clinicians, to receive 100mL of 25% albumin or 0.9% saline placebo BID, for three days, in blinded fashion. We chose five feasibility measurements: enrolment of 50% of eligible patients, at least one patient/week; administration of study treatment within 2h of diuretics in 85% of patients; completion of study regimen in 80% of patients; and avoidance of open label albumin in 85% of patients. Clinical outcomes included fluid balance, ventilator-free days, and mortality. RESULTS We randomized 85% of eligible patients. Eighty-four percent received study treatment within 2h of diuretics, 69% received all doses of study treatment. Study treatment was held in the albumin and placebo groups because of no further need for diuresis (4 vs. 1), hypotension (2 v. 4), and albumin>35 (1 v. 0). Twenty percent of patients received open-label albumin. Clinical outcomes were similar between groups. CONCLUSIONS The current study design did not demonstrate feasibility, but can inform the design of a definitive trial.
Study details
Language : English
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine