FLUDRO

Fludrocortisone therapy in acute hypoxemic respiratory failure with airspace disease.

Domain Lead Investigators

Resources

Domain Description

Objective

The Fludrocortisone in Acute Hypoxemic Respiratory Failure with Airspace Disease (FLUDRO-1) domain is a phase II trial.  The trial aims to provide direct clinical evidence to resolve a critical long-standing question regarding the use of steroids in the treatment of AHRF with airspace disease. 

Population Adult patients admitted to the ICU for less than 72 hours receiving high-flow nasal cannula, non-invasive ventilation, invasive ventilation, or extracorporeal life support for at least 4 consecutive hours for AHRF with new unilateral or bilateral airspace disease.
Primary Endpoint Number of patients recruited per site per month and 60-day mortality
Design

This domain will study the feasibility of adding fludrocortisone to standard of care as a therapy for acute hypoxemic respiratory failure and airspace disease. The domain is divided into two patient arms; participants who will be randomized to receive 1) fludrocortisone plus best practice standard of care, and 2) participants who will receive the best practice standard of care.  FLUDRO-1 is multi-center, pilot, open-label, randomized, controlled trial.

 

Control Group

Name Usual care without fludrocortisone
Description

Best practice standard of care prescribed by treating team without fludrocortisone. After randomization, if a clinical indication develops for fludrocortisone as part of standard of care, administration of fludrocortisone is not prohibited. Any fludrocortisone administered to participants in the control arm will be documented. 

Target sample size 70
Participating sites 3 sites on the PRACTICAL platform

Interventions

  • Intervention Lead investigators
    Eligible states
    Description

    Best practice standard of care prescribed by treating team + fludrocortisone 50μg enterally daily for 7 days. 

    Stage of evaluation
    Primary endpoint
    Active comparator
    Target sample size 70
    Participating sites 3 sites on the PRACTICAL platform