Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome

Patients prospectively classified to the hyper-inflammatory ARDS phenotype on the basis of clinical characteristics and a novel POC biomarker assay will have worse clinical outcomes than the hypo-inflammatory phenotype. Study Aim The purpose of this project is to prospectively identify hyper- and hypo-inflammatory phenotypes in patients with ARDS and determine clinical outcomes associated with each phenotype. The primary objective of this study is to assess the clinical outcomes in patients with ARDS according to their prospectively defined inflammatory phenotype determined using a POC assay. Results of group allocation will be blinded to clinical and research staff until database lock. Secondary Objectives The secondary objectives of this study are to: (i) Assess the agreement of the phenotype allocation using the POC assay and the clinical study dataset. (ii) Assess the stability of phenotype allocation over time (iii) To test feasibility of delivering a POC assay in the NHS intensive care setting.

NCT Number	NCT04009330
Lead Sponsor	Queen's University, Belfast Collaborators: Northern Ireland Clinical Trials Unit, Innovate UK
Conditions	Acute Respiratory Distress Syndrome (ARDS)
Enrollment	480 participants
Start Date	2019-11-22
Primary Completion	2023-11-27 (estimated)
Study Completion	2026-02-27 (estimated)
Updated on ClinicalTrials.gov	2025-07-25