Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht).

Autor: Tas J; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; School for Mental Health and Neuroscience (MHeNS), Maastricht University, Maastricht, The Netherlands., van Gassel RJJ; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.; Department of Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands., Heines SJH; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Mulder MMG; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Heijnen NFL; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Acampo-de Jong MJ; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Bels JLM; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Bennis FC; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Koelmann M; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Groven RVM; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Donkers MA; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., van Rosmalen F; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Biomedical Engineering, Maastricht University, Maastricht, The Netherlands.; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands., Hermans BJM; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands., Meex SJ; Department of Clinical Chemistry, Central Diagnostic Laboratory, Maastricht University Medical Center+, Maastricht, The Netherlands., Mingels A; Department of Clinical Chemistry, Central Diagnostic Laboratory, Maastricht University Medical Center+, Maastricht, The Netherlands., Bekers O; Department of Clinical Chemistry, Central Diagnostic Laboratory, Maastricht University Medical Center+, Maastricht, The Netherlands., Savelkoul P; Department of Medical Microbiology, Maastricht University Medical Centre+, Maastricht, The Netherlands., Oude Lashof AML; Department of Medical Microbiology, Maastricht University Medical Centre+, Maastricht, The Netherlands., Wildberger J; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.; Department of Radiology, Maastricht University Medical Centre+, Maastricht, The Netherlands., Tijssen FH; Department of Anesthesiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Buhre W; Department of Anesthesiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Sels JEM; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Cardiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Ghossein-Doha C; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Cardiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Driessen RGH; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Cardiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Kubben PL; Department of Neurosurgery, Maastricht University Medical Centre+, Maastricht, The Netherlands., Janssen MLF; Department of Neurology, Maastricht University Medical Centre+, Maastricht, The Netherlands., Nicolaes GAF; Department of Biochemistry, Maastricht University Medical Center+, Maastricht, The Netherlands., Strauch U; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Geyik Z; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Cardiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Delnoij TSR; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Cardiology, Maastricht University Medical Center+, Maastricht, The Netherlands., Walraven KHM; Department of Pulmonology, Maastricht University Medical Center+, Maastricht, The Netherlands., Stehouwer CD; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.; Department of Internal Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands., Verbunt JAMCF; Department of Rehabilitation Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands., Van Mook WNKA; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., van Santen S; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Schnabel RM; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., Aries MJH; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; School for Mental Health and Neuroscience (MHeNS), Maastricht University, Maastricht, The Netherlands., van de Poll MCG; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.; Department of Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands., Bergmans D; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands., van der Horst ICC; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands.; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands., van Kuijk S; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, The Netherlands., van Bussel BCT; Department of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands bas.van.bussel@mumc.nl.; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Jazyk: angličtina
Zdroj: BMJ open [BMJ Open] 2020 Sep 29; Vol. 10 (9), pp. e040175. Date of Electronic Publication: 2020 Sep 29.
DOI: 10.1136/bmjopen-2020-040175
Abstrakt: Introduction: The course of the disease in SARS-CoV-2 infection in mechanically ventilated patients is unknown. To unravel the clinical heterogeneity of the SARS-CoV-2 infection in these patients, we designed the prospective observational Maastricht Intensive Care COVID cohort (MaastrICCht). We incorporated serial measurements that harbour aetiological, diagnostic and predictive information. The study aims to investigate the heterogeneity of the natural course of critically ill patients with a SARS-CoV-2 infection.
Methods and Analysis: Mechanically ventilated patients admitted to the intensive care with a SARS-CoV-2 infection will be included. We will collect clinical variables, vital parameters, laboratory variables, mechanical ventilator settings, chest electrical impedance tomography, ECGs, echocardiography as well as other imaging modalities to assess heterogeneity of the course of a SARS-CoV-2 infection in critically ill patients. The MaastrICCht is also designed to foster various other studies and registries and intends to create an open-source database for investigators. Therefore, a major part of the data collection is aligned with an existing national intensive care data registry and two international COVID-19 data collection initiatives. Additionally, we create a flexible design, so that additional measures can be added during the ongoing study based on new knowledge obtained from the rapidly growing body of evidence. The spread of the COVID-19 pandemic requires the swift implementation of observational research to unravel heterogeneity of the natural course of the disease of SARS-CoV-2 infection in mechanically ventilated patients. Our study design is expected to enhance aetiological, diagnostic and prognostic understanding of the disease. This paper describes the design of the MaastrICCht.
Ethics and Dissemination: Ethical approval has been obtained from the medical ethics committee (Medisch Ethische Toetsingscommissie 2020-1565/3 00 523) of the Maastricht University Medical Centre+ (Maastricht UMC+), which will be performed based on the Declaration of Helsinki. During the pandemic, the board of directors of Maastricht UMC+ adopted a policy to inform patients and ask their consent to use the collected data and to store serum samples for COVID-19 research purposes. All study documentation will be stored securely for fifteen years after recruitment of the last patient. The results will be published in peer-reviewed academic journals, with a preference for open access journals, while particularly considering deposition of the manuscripts on a preprint server early.
Trial Registration Number: The Netherlands Trial Register (NL8613).
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze: MEDLINE