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

Autor:	Daenen K; Department of Intensive Care, Erasmus University Medical Center, Rotterdam, Netherlands.; Department of Viroscience, Erasmus University Medical Center, Rotterdam, Netherlands., Huijben JA; Department of Intensive Care, Erasmus University Medical Center, Rotterdam, Netherlands., Boyd A; Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, Netherlands.; HIV Monitoring Foundation, Amsterdam, Netherlands.; Infectious Diseases, Amsterdam University Medical Centers, location University of Amsterdam, Amsterdam, Netherlands., Bos LDJ; Department of Intensive Care, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.; Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands., Stoof SCM; Department of Intensive Care, Erasmus University Medical Center, Rotterdam, Netherlands., van Willigen H; Department of Medical Microbiology & Infection Prevention, Amsterdam University Medical Centers, location University of Amsterdam, Amsterdam, Netherlands., Gommers DAMPJ; Department of Intensive Care, Erasmus University Medical Center, Rotterdam, Netherlands., Moeniralam HS; Department of Internal Medicine and Intensive Care, St Antonius Hospital, Nieuwegein, Netherlands., den Uil CA; Department of Intensive Care, Maasstad Ziekenhuis, Rotterdam, Netherlands., Juffermans NP; Department of Intensive Care, Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, Netherlands.; Laboratory of Translational Intensive Care, Erasmus University Medical Center, Rotterdam, Netherlands., Kant M; Department of Pulmonology, Amphia Hospital, Breda, Netherlands.; Department of Intensive Care, Amphia Hospital, Breda, Netherlands., Valkenburg AJ; Department of Anesthesiology and Intensive Care, Isala Clinics, Zwolle, Netherlands., Pillay J; Department of Intensive Care, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.; Department of Pathology and Medical Biology, Groningen Research Institute for Asthma and Chronic Obstructive Pulmonary Disease, University Medical Center Groningen, University of Groningen, Groningen, Netherlands., van Meenen DMP; Department of Intensive Care, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.; Department of Anesthesiology, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands., Paulus F; Department of Intensive Care, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.; Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, Netherlands., Schultz MJ; Department of Intensive Care, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.; Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam University Medical Centers, location Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands., Dalm VASH; Department of Immunology, Erasmus University Medical Center, Rotterdam, Netherlands.; Division of Allergy & Clinical Immunology, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, Netherlands., van Gorp ECM; Department of Viroscience, Erasmus University Medical Center, Rotterdam, Netherlands.; Department of Internal Medicine, Erasmus University Medical Center, Erasmus, Netherlands., Schinkel J; Department of Medical Microbiology & Infection Prevention, Amsterdam University Medical Centers, location University of Amsterdam, Amsterdam, Netherlands., Endeman H; Department of Intensive Care, Erasmus University Medical Center, Rotterdam, Netherlands.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2023 Jun 02; Vol. 12, pp. e48183. Date of Electronic Publication: 2023 Jun 02.
DOI:	10.2196/48183
Abstrakt:	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. (©Katrijn Daenen, Jilske A Huijben, Anders Boyd, Lieuwe D J Bos, Sara C M Stoof, Hugo van Willigen, Diederik A M P J Gommers, Hazra S Moeniralam, Corstiaan A den Uil, Nicole P Juffermans, Merijn Kant, Abraham J Valkenburg, Janesh Pillay, David M P van Meenen, Frederique Paulus, Marcus J Schultz, Virgil A S H Dalm, Eric C M van Gorp, Janke Schinkel, Henrik Endeman, PRoVENT- and PRoAcT-COVID Collaborative Group. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.06.2023.)
Databáze:	MEDLINE
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