PRoAcT-COVID: Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04719182

Collaborator

(none)

1,000

Enrollment

Locations

Anticipated Duration (Months)

500

Patients Per Site

50.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale Many patients with coronavirus disease (COVID-19) need hospital admission for oxygen supplementation. A substantial number of patients need intensive care unit (ICU) admission for escalation of care. ICU doctors and nurses are struggling to provide the best care for patients with COVID-19. Practice of adjunctive and supportive treatments remains uncertain.

Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands, and to determine their independent associations with outcome.

Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially. Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19.

Study design National, multicenter, retrospective observational study. Study population Intensive care unit (ICU) patients with COVID-19.

Methods In this study we will collect data on diverse treatments during the first 28 days in ICU, including (a) the types of oxygen support and awake prone positioning; (b) the types of ventilatory support, (c) rescue therapies for refractory hypoxemia during invasive ventilation (prone positioning, ventilator adjustments, continuous muscle paralysis, and extracorporeal membrane oxygenation); (d) adjunctive treatments, including thromboprophylaxis and anticoagulation, antiviral and immunomodulating therapies, and (e) experimental supportive treatments. Outcomes include duration of each adjunctive treatment, duration of ventilation, incidence of tracheostomy, duration of stay in ICU and mortality until day 90.

Study endpoints A combination of adjunctive treatments, including types of oxygen support, ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation (primary), other adjunctive and supportive treatments, tracheostomy rate; duration of ventilation and ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness Retrospective collection of data regarding adjunctive treatments, and clinical endpoints is without risk for ICU patients.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Pneumonia Thrombosis Thromboembolism Anticoagulants; Increased ARDS, Human	Other: Adjunctive therapies

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Practice of Adjunctive Treatments in Intensive Care Unit Patients With Coronavirus Disease 2019 (PRoAcT-COVID) - an Observational Study in the Netherlands

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021