Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients
Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients
The primary objective of the study is to evaluate cardiac and pulmonary hemodynamic changes
 over time as predictor of disease progression and outcome in COVID-19 patients admitted to
 ICU.

 The primary endpoint is the occurrence of a major event predefined as either: death
 (all-cause mortality) or discharge from ICU (limit of 4 months).

 This is a uni-center prospective observational cohort study with an inclusion period of 2
 months. The end of the study is foreseen in 6 months.
Background COVID-19 can lead to a bilateral pneumonia overwhelming the lungs causing dyspnea
 and respiratory distress. Up to 20% of the infected population is hospitalized and 5% is
 submitted to the intensive care unit (ICU). Up to 31% of patients in ICU develop sepsis and
 61% develop ARDS with a deadly outcome at ICU of 38%. While sepsis typically causes diffuse
 vasodilation, the pulmonary vasculature resistance in ARDS is high. Although heart failure is
 per definition not the cause of ARDS, the resulting elevated pressures in the pulmonary
 circulation affect right and left heart function. Early detection in alterations of cardiac
 and pulmonary hemodynamics might prompt to actions to prevent ARDS.

 Primary objective To evaluate cardiac and pulmonary hemodynamic changes over time as
 predictor of disease progression and outcome in COVID-19 patients admitted to ICU.

 Secondary objective

 -  Analysis of prognostic factors based on the data at initial presentation

 -  Performing a trajectory analysis of the time course during ICU stay to determine what
 leads to optimal outcome - gain insight in the pathophysiology of the cardio-pulmonary
 evolution of COVID-19 pts

 -  Feasibility study for the creation of an individualized expected data-trajectory for new
 cases and continuously updating its visualization in relation to the expected trajectory
 related to an improved outcome

 -  Evaluate how Machine Learning, based on manifold learning for quantifying information
 similarity and its temporal evolution, is able to predict outcome using rich data in a
 limited number of patients Primary Endpoint

 Occurrence of a major event predefined as either:

 -  Death (all-cause mortality)

 -  Discharge from ICU (limit of 4 months) Secondary Endpoint

 -  Decrease of left ventricular (LV) function defined by LV global longitudinal strain
 (GLS) > 5% (absolute value) and LV S' as compared to the initial evaluation

 -  Evolution of LV diastolic function related to prognosis - Doppler Data and ML
 interpretation

 -  Decrease of right ventricular (RV) function by RV GLS > 5% (absolute values) or decrease
 of RV S' to an absolute value <9.5 cm/s

 -  Dynamic RV response to PEEP maneuver to differentiate intrinsic RV dysfunction from
 excessive PEEP.

 -  Changes in pulmonary arterial compliance from RVOT-VTI and PASP Methods Uni-center
 cohort study (Prospective Observational) Duration of the study Duration of the inclusion
 period: 2 months Duration of participation for each patient: average 4 weeks until death
 or discharge from ICU Duration of data processing and reports: 4 months Total duration
 of the study: 6 months
Inclusion Criteria:

 -  Patient admitted to ICU that is COVID-19 positive based on rt-PCR

 -  Ventilated or not ventilated

 -  No restrictions on age

 -  No restrictions on comorbidities or a diversity of underlying pathology (malignancies,
 COPD, …)

 Exclusion Criteria:

 -  Patients that are not COVID-19 tested (rt-PCR) or where the diagnosis is pending.

 -  Patients that refuse their participation in the study.

 -  Patients under legal protection, or deprived of their liberty.

 -  Patients that are so critically ill that a minimum of 1 follow-up is very unlikely to
 be realised