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Trial record 24 of 198 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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
Sponsor:
Collaborators:
Northern Ireland Clinical Trials Unit
Innovate UK
Information provided by (Responsible Party):
DannyMcAuley, Queen's University, Belfast

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.


Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome (ARDS) Diagnostic Test: POC Assay

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Adults in the Intensive Care Setting
Adults in the Intensive Care Setting
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.





Primary Outcome Measures :
  1. The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS. [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Difference in time to extubation [ Time Frame: 60 days ]
  2. Intubation rate in patients on HFNO [ Time Frame: 60 days ]
  3. Reintubation Rate [ Time Frame: 60 days ]
  4. Number of ventilator free days at day 28 [ Time Frame: 28 days ]
  5. Number of days on ventilation [ Time Frame: 60 days ]
  6. Length of ICU stay [ Time Frame: 60 days ]
  7. Length of hospital stay [ Time Frame: 60 days ]
  8. Mortality at day 28 [ Time Frame: 28 days ]
  9. Agreement of phenotype classification using a POC assay and standard laboratory based assays. [ Time Frame: Day 1 and day 3 ]
  10. Agreement of phenotype classification using a POC assay and the clinical study dataset. [ Time Frame: 2 Years ]
  11. Agreement of phenotype classification between day 1 and day 3. [ Time Frame: Day 1 and Day 3 ]
  12. 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
Samples to be retained are: Li heparin plasma, Na3citrate plasma, Serum, Pax-Gene DNA, PBMC, Pax-Gene RNA and Urine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with ARDS in the ICU.
Criteria

Inclusion Criteria:

  1. Patient is receiving mechanical ventilation or high flow nasal oxygen (HFNO)
  2. 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 Criteria:

  1. Age <18 years of age
  2. More than 48 hrs after onset of ARDS
  3. Receiving ECMO at the time of recruitment
  4. Treatment withdrawal imminent within 24 hours
  5. DNAR (Do Not Attempt Resuscitation) order (excluding advance directives) in place
  6. Declined consent
  7. Prisoners

Information from the National Library of Medicine

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


Contacts
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Contact: Christine McNally 02890635794 Christine.mcnally@nictu.hscni.net
Contact: Judith McCrory 02890635794 Judith.mccrory@nictu.hscni.net

Sponsors and Collaborators
Queen's University, Belfast
Northern Ireland Clinical Trials Unit
Innovate UK
Investigators
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Principal Investigator: Professor D McAuley Queens University Belfast

Publications:
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Responsible Party: DannyMcAuley, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT04009330     History of Changes
Other Study ID Numbers: B19/06
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://www.nictu.hscni.net/PHIND

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by DannyMcAuley, Queen's University, Belfast:
hyper and hypo-inflammatory
Phenotypes
POC (point of care)
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury