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)

Abstract

IntroductionThe 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 analysisMechanically 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 disseminationEthical 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 numberThe Netherlands Trial Register (NL8613).

Decreased serial scores of severe organ failure assessments are associated with survival in mechanically ventilated patients; the prospective Maastricht Intensive Care COVID cohort

“…The Maastricht Intensive Care COVID ( MaastrICCht ) cohort study design has been described more extensively elsewhere [ 31 ]. Briefly, this prospective cohort study was conducted in patients admitted to the Intensive Care of the Maastricht University Medical Centre+ (Maastricht UMC+), a tertiary care university teaching hospital in the southern part of the Netherlands.…”

“…During the COVID-19 pandemic, our ICU was rapidly stepwise upgraded to a maximum of 64 beds, consisting of six subunits with 52 beds for COVID-19 patients and two subunits with 12 beds for non-COVID Intensive Care patients. The study was designed to foster other datasets and registries according to the FAIR data principle in collaboration [ 31 ]. The local institutional review board (Medisch Ethische Toetsingscomissie (METC) 2020-1565/ 300523) of the Maastricht UMC+ approved the study, which was performed based on the regulations of Helsinki.…”

“…either death in the ICU or discharged from the ICU). After training by qualified research staff and with daily supervision by a senior investigator, medical research interns and PhD candidates not involved in patient care included participants and collected clinical, physiological, and laboratory variables using a predefined study protocol (extensively described elsewhere) [ 31 ]. For the present study, participants were included from March the 25th, the inception of the cohort, until June the 23 2020.…”

The prevalence of pulmonary embolism in patients with COVID-19 and respiratory decline: A three-setting comparison

“…COVID-19 was confirmed by a positive real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV-2 RNA on a nasal and pharyngeal swab or sputum. COVID-19 was also considered confirmed in patients with a negative RT-PCR but a disease course consistent with COVID-19 and a chest-CT showing pulmonary abnormalities consistent with COVID-19 (CO-RADS 4 or 5 as defined by the Dutch Radiology Society [14,15]).…”

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“…The Maastricht Intensive Care COVID (MaastrICCht) cohort is a prospective cohort study that is conducted in patients admitted to the ICU of the Maastricht University Medical Center (Maastricht UMC þ ). 23 It included 81 patients who had to be intubated and mechanically ventilated and needed to have signs and symptoms of a viral infection including a polymerase chain reaction positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and/or a chest CT scan scored positive based on a CORADS-score of 4 to 5 by a radiologist. 24 Patients were admitted via our emergency HTR (0.3-0.7 IU/mL) and ATIII concentration was >70% for all patients; mean FVIII and fibrinogen were 606% and 7.5 g/L, respectively.…”