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

NCT ID: NCT04719182

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1011 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-04-01

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)

Conditions

Covid19; Pneumonia; Thrombosis; Thromboembolism; Anticoagulants; Increased; ARDS, Human

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Adjunctive therapies

Determine and compare practice of adjunctive and supportive treatments for COVID-19

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Marcus J. Schultz

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC location AMC

Amsterdam, , Netherlands

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

Amsterdam, , Netherlands

Countries

Netherlands

References

van der Ven FLIM, Valk CMA, Blok S, Brouwer MG, Go DM, Lokhorst A, Swart P, van Meenen DMP, Paulus F, Schultz MJ; PRoAcT-COVID study investigators. Broadening the Berlin definition of ARDS to patients receiving high-flow nasal oxygen: an observational study in patients with acute hypoxemic respiratory failure due to COVID-19. Ann Intensive Care. 2023 Jul 14;13(1):64. doi: 10.1186/s13613-023-01161-6.

Reference Type: DERIVED

PMID: 37452196 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34268426 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRoAcT-COVID

Identifier Type: -

Identifier Source: org_study_id