Practice of adjunctive treatments in critically ill COVID–19 patients—rational for the multicenter observational PRoAcT-COVID study in The Netherlands

Valk, Christel M. A.; Swart, Pien; Boers, Leonoor S.; Botta, Michela; Bos, Lieuwe; Abreu, Marcelo Gama de; Hol, Liselotte; Hollmann, Markus W.; Horn, Janneke; Martín‐Loeches, Ignacio; Mazzinari, Guido; Myatra, Sheila Nainan; Nijbroek, Sunny G. L. H.; Rosenberg, Neeltje M.; Stilma, Willemke; Tsonas, Anissa M.; Ven, Ward H. van der; Neto, Ary Serpa; Schultz, Marcus J.; Paulus, Frederique

doi:10.21037/atm-21-764

Cited by 6 publications

(8 citation statements)

References 38 publications

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“…This is a preplanned analysis of PRoAcT–COVID [ 15 ], an investigator-initiated, nationwide, multicenter, observational study in critically ill acute hypoxemic COVID-19 patients admitted to an intensive care unit (ICU) in the first 3 months of the second wave of the national outbreak in the Netherlands. The study protocol was approved by local institutional Review Board of the Amsterdam UMC, location ‘AMC’.…”

Section: Methodsmentioning

confidence: 99%

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

van der Ven,

Valk,

Blok

et al. 2023

Ann. Intensive Care

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Background High-flow nasal oxygen (HFNO) is increasingly used in patients with acute hypoxemic respiratory failure. It is uncertain whether a broadened Berlin definition of acute respiratory distress syndrome (ARDS), in which ARDS can be diagnosed in patients who are not receiving ventilation, results in similar groups of patients receiving HFNO as in patients receiving ventilation. Methods We applied a broadened definition of ARDS in a multicenter, observational study in adult critically ill patients with acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19), wherein the requirement for a minimal level of 5 cm H2O PEEP with ventilation is replaced by a minimal level of airflow rate with HFNO, and compared baseline characteristics and outcomes between patients receiving HFNO and patients receiving ventilation. The primary endpoint was ICU mortality. We also compared outcomes in risk for death groups using the PaO2/FiO2 cutoffs as used successfully in the original definition of ARDS. Secondary endpoints were hospital mortality; mortality on days 28 and 90; need for ventilation within 7 days in patients that started with HFNO; the number of days free from HFNO or ventilation; and ICU and hospital length of stay. Results Of 728 included patients, 229 patients started with HFNO and 499 patients with ventilation. All patients fulfilled the broadened Berlin definition of ARDS. Patients receiving HFNO had lower disease severity scores and lower PaO2/FiO2 than patients receiving ventilation. ICU mortality was lower in receiving HFNO (22.7 vs 35.6%; p = 0.001). Using PaO2/FiO2 cutoffs for mild, moderate and severe arterial hypoxemia created groups with an ICU mortality of 16.7%, 22.0%, and 23.5% (p = 0.906) versus 19.1%, 37.9% and 41.4% (p = 0.002), in patients receiving HFNO versus patients receiving ventilation, respectively. Conclusions Using a broadened definition of ARDS may facilitate an earlier diagnosis of ARDS in patients receiving HFNO; however, ARDS patients receiving HFNO and ARDS patients receiving ventilation have distinct baseline characteristics and mortality rates. Trial registration: The study is registered at ClinicalTrials.gov (identifier NCT04719182).

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Section: Methodsmentioning

confidence: 99%

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

van der Ven,

Valk,

Blok

et al. 2023

Ann. Intensive Care

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“…This is a preplanned analysis of patients admitted to the ICU of the Amsterdam University Medical Centers (AUMC), location ‘AMC’, Amsterdam, The Netherlands, in two sequential observational studies, named ‘Practice of Ventilation in COVID-19 patients’ (PRoVENT–COVID) [ 14 ], and ‘Practice of Adjunctive Therapies in COVID-19′ (PRoAcT–COVID) [ 15 ]. The first study included patients in the first wave of the national outbreak, from 1 March to 1 June 2020, while the second study included patients in the second wave, from 1 October 2020 to 1 January 2021.…”

Section: Methodsmentioning

confidence: 99%

Incidence of Air Leaks in Critically Ill Patients with Acute Hypoxemic Respiratory Failure Due to COVID-19

et al. 2023

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Subcutaneous emphysema, pneumothorax and pneumomediastinum are well-known complications of invasive ventilation in patients with acute hypoxemic respiratory failure. We determined the incidences of air leaks that were visible on available chest images in a cohort of critically ill patients with acute hypoxemic respiratory failure due to coronavirus disease of 2019 (COVID-19) in a single-center cohort in the Netherlands. A total of 712 chest images from 154 patients were re-evaluated by a multidisciplinary team of independent assessors; there was a median of three (2–5) chest radiographs and a median of one (1–2) chest CT scans per patient. The incidences of subcutaneous emphysema, pneumothoraxes and pneumomediastinum present in 13 patients (8.4%) were 4.5%, 4.5%, and 3.9%. The median first day of the presence of an air leak was 18 (2–21) days after arrival in the ICU and 18 (9–22)days after the start of invasive ventilation. We conclude that the incidence of air leaks was high in this cohort of COVID-19 patients, but it was fairly comparable with what was previously reported in patients with acute hypoxemic respiratory failure in the pre-COVID-19 era.

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“…The focus lies on collecting data from centers that use high-dose corticosteroids on the ward directly after admission and subsequently collecting data from centers with low-dose regimens as a comparison. For the data collection of ICU patients (WP2-3), a collaboration with 2 large COVID-19 study groups is started: the Practice of Ventilation in COVID-19 study (ie, PROVENT-COVID) study and the “Practice of Adjunctive Treatments in Intensive Care Unit Patients with Coronavirus Disease 2019” (PROACT-COVID) study [ 20 , 21 ]. The data of interest will be collected in Castor EDC [ 22 ], and it will be imported from each center via a secured data transfer system.…”

Section: Methodsmentioning

confidence: 99%

Optimal Dosing and Timing of High-Dose Corticosteroid Therapy in Hospitalized Patients With COVID-19: Study Protocol for a Retrospective Observational Multicenter Study (SELECT)

Daenen¹,

Huijben²,

Boyd³

et al. 2023

JMIR Res Protoc

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Background In hospitalized patients with COVID-19, the dosing and timing of corticosteroids vary widely. Low-dose dexamethasone therapy reduces mortality in patients requiring respiratory support, but it remains unclear how to treat patients when this therapy fails. In critically ill patients, high-dose corticosteroids are often administered as salvage late in the disease course, whereas earlier administration may be more beneficial in preventing disease progression. Previous research has revealed that increased levels of various biomarkers are associated with mortality, and whole blood transcriptome sequencing has the ability to identify host factors predisposing to critical illness in patients with COVID-19. Objective Our goal is to determine the most optimal dosing and timing of corticosteroid therapy and to provide a basis for personalized corticosteroid treatment regimens to reduce morbidity and mortality in hospitalized patients with COVID-19. Methods This is a retrospective, observational, multicenter study that includes adult patients who were hospitalized due to COVID-19 in the Netherlands. We will use the differences in therapeutic strategies between hospitals (per protocol high-dose corticosteroids or not) over time to determine whether high-dose corticosteroids have an effect on the following outcome measures: mechanical ventilation or high-flow nasal cannula therapy, in-hospital mortality, and 28-day survival. We will also explore biomarker profiles in serum and bronchoalveolar lavage fluid and use whole blood transcriptome analysis to determine factors that influence the relationship between high-dose corticosteroids and outcome. Existing databases that contain routinely collected electronic data during ward and intensive care admissions, as well as existing biobanks, will be used. We will apply longitudinal modeling appropriate for each data structure to answer the research questions at hand. Results As of April 2023, data have been collected for a total of 1500 patients, with data collection anticipated to be completed by December 2023. We expect the first results to be available in early 2024. Conclusions This study protocol presents a strategy to investigate the effect of high-dose corticosteroids throughout the entire clinical course of hospitalized patients with COVID-19, from hospital admission to the ward or intensive care unit until hospital discharge. Moreover, our exploration of biomarker and gene expression profiles for targeted corticosteroid therapy represents a first step towards personalized COVID-19 corticosteroid treatment. Trial Registration ClinicalTrials.gov NCT05403359; https://clinicaltrials.gov/ct2/show/NCT05403359 International Registered Report Identifier (IRRID) DERR1-10.2196/48183

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Practice of adjunctive treatments in critically ill COVID–19 patients—rational for the multicenter observational PRoAcT-COVID study in The Netherlands

Cited by 6 publications

References 38 publications

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

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

Incidence of Air Leaks in Critically Ill Patients with Acute Hypoxemic Respiratory Failure Due to COVID-19

Optimal Dosing and Timing of High-Dose Corticosteroid Therapy in Hospitalized Patients With COVID-19: Study Protocol for a Retrospective Observational Multicenter Study (SELECT)

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