Clinical trial NCT04719182: Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19
Official title: Practice of Adjunctive Treatments in Intensive Care Unit Patients With Coronavirus Disease 2019 (PRoAcT-COVID) - an Observational Study in the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Pneumonia
Thrombosis
Thromboembolism
Anticoagulants; Increased
ARDS, Human
Keywords: ARDS
COVID-19
Lungembolism
DVT
PPI
Adjunctive therapies
Mechanical ventilation
Prone positioning
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 1011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe coronavirus disease 2019 (COVID-19) admitted to intensive care units (ICUs) in the Netherlands between September 2020 and January 2021 (i.e. during the second surge of COVID-19 patients).

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/international, 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.

\*In a subset of patients we will collect granular data (every two hours) regarding oxygenation (FiO2, inspiratory tidal volume, air flow, respiratory rate, SpO2, PaO2, and PEEP) over the first 2 full calendar days of ICU admission. The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions. The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study, and one additional ICU in Spain is uploaded in the document section (filename Statistical Analysis Plan PROXY-COVID)


Eligibility criteria: Inclusion Criteria:

* COVID-19, confirmed with PCR; and
* Admission to one of the participating ICUs, or an emergency location that serves as an ICU during the pandemic.

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Mortality
timeFrame: 90 days
measure: ICU, hospital and 90-day mortality
timeFrame: 90 days
measure: Ventilator-free days and alive at day 28
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 90 days
Secondary outcomes:
measure: Proven deep vein thrombosis (DVT)
timeFrame: 28 days
measure: Incidence of gastrointestinal bleeding
timeFrame: 28 days
measure: Development of acute kidney injury (AKI)
timeFrame: 28 days
measure: Incidence of tracheostomy
timeFrame: 28 days
measure: Use of renal replacement therapy (RRT)
timeFrame: 28 days
measure: Proven pulmonary embolism (PE)
timeFrame: 28 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study officials:
References:
citation: Valk CMA, Swart P, Boers LS, Botta M, Bos LDJ, de Abreu MG, Hol L, Hollmann MW, Horn J, Martin-Loeches I, Mazzinari G, Myatra SN, Nijbroek SG, Rosenberg NM, Stilma W, Tsonas AM, van der Ven WH, Neto AS, Schultz MJ, Paulus F. Practice of adjunctive treatments in critically ill COVID-19 patients-rational for the multicenter observational PRoAcT-COVID study in The Netherlands. Ann Transl Med. 2021 May;9(9):813. doi: 10.21037/atm-21-764.