GuARDS Trial

A UK-wide clinical trial involving 65 hospitals, exploring dexamethasone treatment in patients with acute respiratory distress syndrome (ARDS).

Aim of the Trial

The aim of our study is to answer if dexamethasone treatment in patients with ARDS can save lives, reduce the need for extended ICU care, improve longer term patient quality of life and find the best value for the public and health services.

Overview

Every year about 120,000 adults who are admitted to Intensive Care Units (ICUs) require a machine, called a ventilator, to help them breathe. In patients who need ventilation, about 1 in 4 have a life-threatening condition with severe breathing difficulties called acute respiratory distress syndrome (ARDS). Unfortunately, around 40% of patients with ARDS die within 60 days of developing this condition.

Breathing difficulties in ARDS happen because the lungs fill with fluid because of inflammation, which is part of the body’s response to the conditions causing ARDS.

Over the last 30-years, various drug treatments have been tested to reduce the inflammation in ARDS, with limited success. At present, there are no drugs that cure ARDS. However, in 2020, a small research study (the DEXA-ARDS trial) in Spain looked at dexamethasone as a treatment for ARDS. Dexamethasone is a well-known steroid, which is a cheap anti-inflammation drug, that is already widely used to treat other illnesses. The result of DEXA-ARDS trial showed that it may help patients survive ARDS.

These results from Spain are encouraging but to help us know how effective dexamethasone is, we need to test it in a much bigger group of patients who come into the NHS with ARDS. We are planning to conduct a large clinical trial across the UK.

Clinical Trial

This clinical trial is scheduled to begin in March 2023. Adult patients with ARDS will be recruited from approximately 65 ICUs throughout the UK.

The title of the project is Glucocorticoids in adults with Acute Respiratory Distress Syndrome (GuARDS Trial): A randomised, parallel-group, allocation-concealed, open label, pragmatic, group sequential design, clinical and cost- effectiveness trial with internal pilot.

Contact Information

Chief Investigators - Professor Manu Shankar-Hari and Professor Danny McAuley

GuARDS Contact - Trial Manager, Kay Russell - Kay.russell@roslin.ed.ac.uk

Funded by NIHR HTA Programme.