Status:
ACTIVE_NOT_RECRUITING
Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
Northern Ireland Clinical Trials Unit
Innovate UK
Conditions:
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18+ years
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-infl...
Detailed Description
Acute respiratory distress syndrome (ARDS) is an inflammatory condition that results in severe respiratory failure and the need for mechanical ventilation. It is a syndrome with significant global bur...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 27 2026
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04009330
Start Date
November 22 2019
End Date
February 27 2026
Last Update
July 25 2025
Active Locations (22)
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1
St Vincents Hospital
Dublin, Ireland, Ireland, D04 T6F4
2
University Hospital Birmingham
Birmingham, England, United Kingdom, B15 2TH
3
Royal Blackburn Hospital
Blackburn, England, United Kingdom, BB2 3HH
4
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP