Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
PHIND
Clinical Evaluation of a POC Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
1 other identifier
observational
480
2 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
November 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2026
CompletedJuly 25, 2025
July 1, 2025
4 years
May 15, 2019
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS.
The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS.
60 days
Secondary Outcomes (12)
Difference in time to extubation
60 days
Intubation rate in patients on HFNO
60 days
Reintubation Rate
60 days
Number of ventilator free days at day 28
28 days
Number of days on ventilation
60 days
- +7 more secondary outcomes
Study Arms (1)
Adults in the Intensive Care Setting
Adults in the Intensive Care Setting
Interventions
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.
Eligibility Criteria
Patients with ARDS in the ICU.
You may qualify if:
- Patient is receiving mechanical ventilation or high flow nasal oxygen (HFNO)
- ARDS as defined by the Berlin definition (Ranieri et al.) a) Onset within 1 week of identified insult b) Within the same 24-hour time period: i. Hypoxic respiratory failure (PaO2/ FiO2 ratio ≤ 40kPa on PEEP ≥ 5 cmH20\*) ii. Bilateral infiltrates consistent with pulmonary oedema not explained by another pulmonary pathology iii. Respiratory failure not fully explained by cardiac failure or fluid overload
- The time of onset of ARDS is when the last ARDS criterion is met.
- \*PEEP assumed ≥ 5 cmH20 if on HFNO.
You may not qualify if:
- Age \<18 years of age
- More than 48 hrs after onset of ARDS
- Receiving ECMO at the time of recruitment
- Treatment withdrawal imminent within 24 hours
- DNAR (Do Not Attempt Resuscitation) order (excluding advance directives) in place
- Declined consent
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- Northern Ireland Clinical Trials Unitcollaborator
- Innovate UKcollaborator
Study Sites (22)
St Vincents Hospital
Dublin, Ireland, D04 T6F4, Ireland
University Hospital Birmingham
Birmingham, England, B15 2TH, United Kingdom
Royal Blackburn Hospital
Blackburn, England, BB2 3HH, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, L7 8XP, United Kingdom
University College London
London, England, NW1 2BU, United Kingdom
Guys and St Thomas Hospital
London, England, SE1 7EH, United Kingdom
Kings College Hospital
London, England, SE5 9RS, United Kingdom
Wythenshawe Hospital
Manchester, England, M23 9QZ, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Freemans Hospital
Newcastle upon Tyne, England, United Kingdom
Nottingham University Hospital
Nottingham, England, NG7 2UH, United Kingdom
Royal Berkshire Hospital
Reading, England, RG1 5AN, United Kingdom
Sunderland Royal
Sunderland, England, SR4 7TP, United Kingdom
Royal Cornwall Hospital
Truro, England, TR1 3LI, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, Scotland, EH16 4SB, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Royal Gwent Hospital
Newport, Wales, NP18 3XQ, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Imperial College London
London, United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
Related Publications (1)
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PMID: 22797452BACKGROUND
Biospecimen
Samples to be retained are: Li heparin plasma, Na3citrate plasma, Serum, Pax-Gene DNA, PBMC, Pax-Gene RNA and Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor D McAuley
Queens University Belfast
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 15, 2019
First Posted
July 5, 2019
Study Start
November 22, 2019
Primary Completion
November 27, 2023
Study Completion
February 27, 2026
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Following the publication of the primary and secondary outcomes.
- Access Criteria
- Formal requests for data will need to be made in writing to the CI via the Northern Ireland Clinical Trials Unit, who will discuss this with the sponsor.
Following the publication of the primary and secondary outcomes there may be scope to conduct additional analyses on the data collected. In such instances formal requests for data will need to be made in writing to the CI via the Northern Ireland Clinical Trials Unit, who will discuss this with the sponsor.