PHIND

• Research type

  Research Study

• Full title

  Clinical evaluation of a Point of Care (POC) assay to identify PHenotypes IN the Acute Respiratory Distress Syndrome

• IRAS ID

  263873

• Contact name

  Daniel Francis McAuley

• Contact email

  d.f.mcauley@qub.ac.uk

• Sponsor organisation

  Queen's University Belfast

• Duration of Study in the UK

  3 years, 5 months, 31 days

• Research summary

  Acute Respiratory Distress Syndrome (ARDS) is a life threatening condition in critically ill patients, caused by infection or injury which can induce inflammation in the lungs, causing them to fill up with fluid. ARDS often progresses to further injury to other organs in the body, and is associated with high rates of mortality or long term disability in survivors. ARDS is estimated to affect 40,000 patients annually in the UK, 200,000 in the US and 3 million globally. Mortality rates range between 30-45%, depending on initial severity at diagnosis. There is no effective drug treatment for the condition despite numerous clinical trials to evaluate possible candidates. New evidence suggests that previously tried and discounted drugs may benefit certain patient sub-groups. ARDS patients with very high levels of certain markers of inflammation are more likely to respond to certain therapies. Several blood biomarkers have been identified to allow identification of these hyper-inflamed patients. To allow rapid identification of the hyper-inflamed patient with ARDS, and hence guide the most effective therapy at the point of admission to Intensive Care Units, a near-patient theranostic (a diagnostic test designed to personalise therapeutic interventions) test is required.
  Working with a biomarker test developed by Randox, this study will further develop this test to allow rapid near-patient classification, using a new point of care (POC) diagnostic analyser. We will co-ordinate a multi-centre clinical evaluation across Intensive Care Units in the UK to show that the test can be used at point of care to accurately classify patients into hyper-inflamed and hypo-inflamed phenotypes (sub-groups). This will inform future therapy decisions. The project thus aims to develop a theranostic ARDS test and prove it is effective in identifying critically ill patients that may be more likely to respond to a personalised therapy.

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  19/SS/0073

• Date of REC Opinion

  28 Jun 2019

• REC opinion

  Favourable Opinion