Effect of Nebulized Furosemide on the Mortality of Adult, Mechanically Ventilated Acute Respiratory Distress Syndrome (ARDS) Patients: Protocol of a Randomized Clinical Trial (The ENHALE Trial)

Abstract

Background Acute respiratory distress syndrome (ARDS) affects a significant proportion of ICU patients and has a high mortality rate. The inflammation of the alveolar-capillary membrane is pathognomonic and characterized by increased capillary permeability and pulmonary edema. A safe, readily available anti-inflammatory agent delivered directly to the lungs could be a promising therapeutic approach. All these properties apply to nebulized furosemide. Objectives The primary objective of this study is to analyze 28-day all-cause ICU mortality while the secondary objectives include assessing hospital mortality, ICU and hospital length of stay (LOS), ventilator-free days at 28 days, successful extubation rate, and adverse events. Methods A double-blind, placebo-controlled, parallel-arm superiority RCT using an intention-to-treat (ITT) analysis to assess whether nebulized furosemide reduces mortality in adult mechanically ventilated ARDS patients will be employed. Results The results of descriptive and inferential analyses will be tabulated, and the significant results will be presented.