# 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)

## TL;DR

This clinical trial aims to determine if nebulized furosemide reduces mortality in adult patients with ARDS who are on mechanical ventilation.

## Contribution

The study introduces a novel approach of using nebulized furosemide as a potential treatment for ARDS.

## Key findings

- The trial will assess 28-day ICU mortality as the primary outcome.
- Secondary outcomes include hospital mortality and ventilator-free days.
- Adverse events will be monitored to evaluate safety.

## 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.