FAST-3

Nebulized Furosemide for the Treatment of Pulmonary Inflammation in Patients with Respiratory Failure Secondary to Pulmonary Infection – A Phase 3 study

Domain Lead Investigators

Resources

Domain Description

Objective

The Nebulized Furosemide for the Treatment of Pulmonary Inflammation in Patients with Respiratory Failure Secondary to Pulmonary Infection domain is a phase III trial.  It aims to use nebulized furosemide as supportive therapy to improve Advanced Respiratory Support (ARS) free days up to day 28 in critically ill patients with AHRF. 

Population There is no fixed sample size in this Bayesian adaptive randomized controlled trial. We will recruit a minimum of 500 patients in total before commencing interim analyses, and a maximum of 1,540 patients.
Primary Endpoint Advanced respiratory support free days (ARSFDs) to day 28, a composite outcome including mortality and requirement for respiratory support.
Design

This multicenter, randomized, controlled, double-blind study domain will study the nebulization of furosemide as supportive therapy for Acute Hypoxemic Respiratory Failure. The domain is divided into two patient strata; patients with DRI AHRF and patients with non-DRI AHRF. Both strata will be analyzed in aggregate in an intention to treat (ITT) analysis but will then be analyzed independently for assessment of heterogeneity of effect.

This is a phase 3, Bayesian adaptive, superiority study powered on patient centered outcomes.

Control Group

Name DRI AHRF Stratum
Description

Patients with a direct respiratory infection -Control Arm: 4 mL of nebulized 0.9% saline minutes every 6 hours over 30 minutes every 6 hours.

Target sample size
Participating sites
Name non-DRI AHRF Stratum
Description

Patients without a direct respiratory infection -Control Arm: 4 mL of nebulized 0.9% saline minutes every 6 hours over 30 minutes every 6 hours.

Target sample size
Participating sites

Interventions

  • Intervention Lead investigators
    Eligible states

    Patients whose Acute Hypoxemic Respiratory Failure (AHRF) is caused by direct respiratory infection (DRI AHRF) and patients whose AHRF is not caused by direct respiratory infection such as non-infectious pulmonary injury or systemic disease such as sepsis (non-DRI AHRF). Both strata have identical intervention and control arms.

    Description

    Intervention Arm: 40 mg of nebulized furosemide in 4 mL of saline nebulized over 30 minutes every 6 hours.

    Stage of evaluation
    Primary endpoint

    Advanced respiratory support free days (ARSFDs) to day 28, a composite outcome including mortality and requirement for respiratory support.

    Active comparator
    Target sample size
    Participating sites