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

NCT04009330 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2025-07-25

No results posted yet for this study

Summary

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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Interventions

DIAGNOSTIC_TEST

POC Assay

Interventions: Blood Baseline - up to 40ml Day 3 - up to 40ml Urine Baseline - 10ml Day 3 - 10ml Study population: Adults (18 plus) in ICU units diagnosed with ARDS.

Sponsors & Collaborators

  • Northern Ireland Clinical Trials Unit

    collaborator OTHER

  • Innovate UK

    collaborator OTHER_GOV

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Professor D McAuley · Queens University Belfast

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2023-11-27
Completion
2026-02-27

Countries

  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009330 on ClinicalTrials.gov