Clinical Evaluation of a POC Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 22
- 主要终点
- The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS.
研究概览
简要总结
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.
详细描述
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 burden and accounts for approximately 24% of mechanically ventilated patients in intensive care units. It is estimated to account for approximately 75000 deaths annually in the USA alone.
Despite decades of research, mortality due to ARDS remains high at 35-46%, with increasing mortality in patients with more severe lung injury. ARDS survivors have significant long term comorbidity with reduced quality of life even 5 years after disease resolution. Various pharmacological agents such as β2 agonists, statins, keratinocyte growth factor and aspirin have been investigated as potential therapies to prevent or treat ARDS, however to date there is no effective pharmacological therapy for ARDS and current treatment strategy is largely supportive.
One reason for the lack of specific pharmacological therapy is likely due to the clinical and biological heterogeneity. It is essential to rapidly identify patients with specific therapy responsive traits to improve our chance of identifying a specific therapy.
Rationale for the Study
ARDS phenotypes have different outcomes and response to therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS.
时间窗: 60 days
The primary outcome is mortality at 60 days in the hyper-inflammatory and hypo-inflammatory phenotypes in patients with ARDS.
次要结局
- Difference in time to extubation(60 days)
- Number of ventilator free days at day 28(28 days)
- Number of days on ventilation(60 days)
- Length of hospital stay(60 days)
- Frequency of assay technical failure rate will be used to determine the feasibility of delivering a POC assay in NHS intensive care setting.(2 years)
- Agreement of phenotype classification using a POC assay and the clinical study dataset.(2 Years)
- Intubation rate in patients on HFNO(60 days)
- Reintubation Rate(60 days)
- Length of ICU stay(60 days)
- Mortality at day 28(28 days)
- Agreement of phenotype classification using a POC assay and standard laboratory based assays.(Day 1 and day 3)
- Agreement of phenotype classification between day 1 and day 3.(Day 1 and Day 3)
研究者
DannyMcAuley
Professor
Queen's University, Belfast