No registrations found.
ID
Source
Brief title
Health condition
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical data, laboratory results, EIT measurements and vital parameters will be collected within the MaastrICCht cohort. As multiple hypotheses can be investigated within the observational cohort, no predefined primary outcome for the whole cohort will be defined.
Rather, investigators have to submit a data request including a predefined analysis plan according to reporting guidelines appropriate for the type of study (i.e., STROBE for observational studies, STARD for diagnostic studies, TRIPOD for prognostic studies; see the Enhancing the QUAlity and Transparency Of health Research network at www.equator-network.org for detailed information). All external researchers submitting a data request will be required to produce a statistical analysis plan that will be reviewed by the cohort steering committee.
Secondary outcome
x
Background summary
We will collect clinical variables, vital parameters, laboratory variables, mechanical ventilator settings, chest electrical impedance tomography, electrocardiograms, echocardiography as well as other imaging modalities to assess heterogeneity of the natural course of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in critically ill patients. The MaastrICCht cohort 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.
Objectives:
1) Investigate the longitudinal relationship between changes in the PF ratio and changes in EIT bio-markers over the course of SARS-CoV-2 induced ARDS .
2) Investigate whether changes in the PF ratio and changes in EIT biomarkers are related to prone position.
3) Investigate whether changes in PF ratio and changes in EIT biomarkers are associated with mortality.
4) Investigate the development of multi-organ failure over time in intensive care patients on mechanical ventilation with SARS-CoV-2 infection; comparing survivors vs deceased.
Study objective
We hypothesize that a comprehensive characterization of the heterogeneity of the natural course of critically ill patients with SARS-CoV-2 will enhance our aetiologic, diagnostic and prognostic understanding of the disease, which ultimately helps to guide Intensive Care resources and patient care.
Multiple hypotheses will be investigated, including but not limited to:
- phenotyping COVID-19 induced respiratory disease using EIT biomarkers during mechanical ventilation could optimize ventilation, timing of prone positioning and possibly affect outcome.
- mechanically ventilated patients, admitted to the Intensive Care Unit (ICU) with SARS-CoV-2 infection who survived the intensive care, have a more favourable development of multi-organ failure over time as compared to patients that died.
Study design
On admission to the ICU, data will be collected regarding demographics, comorbidities, clinical variables, critical illness severity scores (APACHE II, SAPS II) and vital parameters.
Daily measurements are recorded regarding vital parameters, laboratory results, ventilator settings and interventions (including medication, dialysis and ECMO) for the duration of ICU stay.
Finally, outcome variables such as mortality, cause of death, mechanical ventilation days, proning, readmission, etc. are collected.
Intervention
None.
Inclusion criteria
- Intensive care admission with signs and symptoms of a viral infection
- Intubated and mechanically ventilated
- PCR positive for SARS-CoV-2 and/or a chest CT scan scored positive based on a CORADS-score of 4-5 by a radiologist
Exclusion criteria
None.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8613 |
| Other | Local institutional review board (METc) of the Maastricht UMC+. : 2020-1565 |