Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome (PHIND)
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|ClinicalTrials.gov Identifier: NCT04009330|
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : August 12, 2019
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.
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.
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.
|Condition or disease||Intervention/treatment|
|Acute Respiratory Distress Syndrome (ARDS)||Diagnostic Test: POC Assay|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||480 participants|
|Official Title:||Clinical Evaluation of a POC Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Adults in the Intensive Care Setting
Adults in the Intensive Care Setting
Diagnostic Test: POC Assay
Blood Baseline - up to 40ml Day 3 - up to 40ml
Urine Baseline - 10ml Day 3 - 10ml
Adults (18 plus) in ICU units diagnosed with ARDS.
- The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS. [ Time Frame: 60 days ]
- Difference in time to extubation [ Time Frame: 60 days ]
- Intubation rate in patients on HFNO [ Time Frame: 60 days ]
- Reintubation Rate [ Time Frame: 60 days ]
- Number of ventilator free days at day 28 [ Time Frame: 28 days ]
- Number of days on ventilation [ Time Frame: 60 days ]
- Length of ICU stay [ Time Frame: 60 days ]
- Length of hospital stay [ Time Frame: 60 days ]
- Mortality at day 28 [ Time Frame: 28 days ]
- Agreement of phenotype classification using a POC assay and standard laboratory based assays. [ Time Frame: Day 1 and day 3 ]
- Agreement of phenotype classification using a POC assay and the clinical study dataset. [ Time Frame: 2 Years ]
- Agreement of phenotype classification between day 1 and day 3. [ Time Frame: Day 1 and Day 3 ]
- Frequency of assay technical failure rate will be used to determine the feasibility of delivering a POC assay in NHS intensive care setting. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009330
|Contact: Christine McNally||02890635794||Christine.email@example.com|
|Contact: Judith McCrory||02890635794||Judith.firstname.lastname@example.org|
|Principal Investigator:||Professor D McAuley||Queens University Belfast|