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临床试验/NCT04729075
NCT04729075已完成不适用

Towards Precision Medicine for COVID-19 ARDS - An Analysis of the NorthCARDS (Northwell Health COVID-19 ARDS) Dataset to Identify Associations Between Patient-level Factors, Inpatient Treatment and Clinical Trajectories on Mechanical Ventilation Liberation and Survival

Northwell Health1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2021年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,800
试验地点
1
主要终点
Index Hospital Survival

研究概览

简要总结

The mortality rates associated with COVID-19 related ARDS (COVIDARDS) have varied from observational reports from around the world. This has ranged from 44% (28 day mortality) in the UK to 36% (28 day mortality from ICU admission) in Italian studies, to 32% (all-cause 28 day mortality) in Spain. Predictive models have identified risk factors for COVID-19 hospitalized patients' mortality to include male sex, obesity, age, obesity, comorbidities including chronic lung disease and hypertension, as well as biomarkers including high levels of D-Dimer, LDH and CRP. In addition, practice patterns, such as drugs that were administered, timing of mechanical ventilation and adherence to established lung protective ventilation protocols are known to be variable across sites and have changed over time.

The investigators propose to analyze outcomes for patients with COVIDARDS within the NorthCARDS dataset (a dataset of over 1500 patients with COVID-19 related ARDS across the Northwell Health System in the NYC metropolitan region and Long Island, NY) to understand differences in hospital survival and in the time to liberation from mechanical ventilation, specifically looking at the associations between baseline patient factors, changes in biomarkers, respiratory function and hemodynamics over time, and treatments administered. The analyses will be based on three hypotheses:

H.1. Worsening trajectories of: oxygenation index (OI), respiratory system compliance (C), and inflammatory markers will be associated with lower hospital survival.

H.2. Higher duration of deep sedation and paralytics will be associated with greater time to liberation from mechanical ventilation. This risk will be increased in patients with worsening trajectories of OI, C, and inflammatory markers over time.

H.3. Type of mechanical ventilator, specifically the time on portable mechanical ventilator, is associated with hospital mortality and with inability to liberate from mechanical ventilator despite controlling for risk factors of changes in OI, C and Inflammatory markers over time, and the use of paralytics and deep sedation.

详细描述

The investigators will leverage the NorthCARDS dataset for this analysis. This dataset includes over 1500 persons admitted to the Northwell Health System who had PCR positive COVID19 testing and were invasively mechanically ventilated for ARDS. Registry development was initiated in April 2020 and continues with prospective data collection for all mechanically ventilated COVID19 ARDS patients among the Northwell Health hospitals. Data structuring and engineering is informed by weekly multi-disciplinary review including frontline clinicians, data scientists, biostatisticians and data engineers within medical informatics. Random selection of patients for individual 'manual' chart review occurs for data assumptions and recording.

The two outcomes to be modeled using multivariable regression analyses will be:

  1. Index hospital survival and
  2. Time to liberation from mechanical ventilation.

Liberation from mechanical ventilation will be defined as non-palliative extubation and persistent extubation for greater than one week. Outcomes will be obtained from electronic health record queries. Patients in whom the investigators do not have outcomes data by November 30,2020 will be censored in analyses, and descriptive statistics will be summarized and presented separately.

The investigators will approach this analysis using both hypothesis-driven methods wherein known risk factors for poor outcomes will be included in the multivariable regression models (logistic regression for Model 1, and Cox Proportional Hazards for Model 2); and investigators will also perform data-driven variable selection for the models. A priori defined risk factors that will be included in the models will be: Age, Gender, BMI, functional status at baseline (nursing home versus community admission), Comorbidities (coronary artery disease, Chronic Kidney Disease, Neurologic disorders, COPD, Diabetes, Active cancer, Hypertension); Inpatient treatments (for continuous values will be (max, median, trajectory)) including PEEP levels, Driving Pressure, FiO2, hypoxemia (Pao2:Fio2), type of mechanical ventilator (portable versus not), COVID-targeted medications (e.g., azithromycin, hydroxychloroquine, corticosteroids); and end-organ damage in-hospital: liver dysfunction, Kidney dysfunction, coagulopathy, (captured via SOFA scores), cardiac dysfunction, and shock requiring vasopressor/inotrope. Calendar-time, hospital type (community versus tertiary hospital) and hospital capacity (measured as number of hospital beds filled and time from admission order in ER to being transferred to an inpatient bed) will also be included in the analyses to account for temporal and systemic influences of outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Inpatients at any of the hospitals within the Northwell Health system
  • COVID19 PCR positive
  • meeting ARDS criteria (defined as)
  • PaO2:FiO2 <300 for at least 2 consecutive values (including 2 S/F values)
  • bilateral infiltrates
  • mechanical ventilation (NIMV or IMV with PEEP 5)
  • Timeframe March 1, 2020 until December 30, 2020

排除标准

  • Patients admitted for surgical procedures
  • infiltrates described as being due to cardiogenic pulmonary edema without COVID-19 pneumonia
  • improvement of paO2:FiO2 to > 300 within 48 hours

结局指标

主要结局

Index Hospital Survival

时间窗: up to 1 year

Through duration of hospital stay for up to 1 year

Time to Mechanical Ventilator Liberation

时间窗: 6 months

Censored at 6-months of follow-up; Liberation from mechanical ventilation will be defined as non-palliative extubation and persistent extubation for greater than one week.

次要结局

  • Hospital Readmission(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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