Domain Lead Investigators
Resources
- Download FLUDRO-1 Protocol (pdf:1.1MB)
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