NCT04729075: NorthCARDS

Associations Between COVID-19 ARDS Treatment, Clinical Trajectories and Liberation From Mechanical Ventilator - an Analysis of the NorthCARDS Dataset

Completed Last updated 4 April 2023

What this trial tests

trial testing ARDS and COVID19 treatments in ARDS, Human in 1,800 participants. Completed in 19 January 2021.

Timeline

19 January 2021

Primary endpoint
19 January 2021

19 January 2021

Quick facts

Lead sponsor	Northwell Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,800
Start date	19 January 2021
Primary completion	19 January 2021
Estimated completion	19 January 2021
Sites	1 location across United States

Drugs / interventions tested

• ARDS and COVID19 treatments

Conditions studied

• ARDS, Human — all drugs for ARDS, Human →
• Covid19 — all drugs for Covid19 →

Sponsor

Northwell Health — full company profile →

Who can join

Eligibility, any sex, with ARDS, Human or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Drivers of Mortality in COVID ARDS Depend on Patient Sub-Type
   Cheyne H, Gandomi A, Vajargah SH, Catterson VM, et al · · 2022 · DOI 10.1101/2022.07.04.22277239