The primary objective of the study is to evaluate cardiac and pulmonary hemodynamicchanges over time as predictor of disease progression and outcome in COVID-19 patientsadmitted 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 2months. 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
Other: No interventions planned
No interventions planned. Observational.
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
Jessa Hospital
Hasselt, Belgium
Investigator: Lieven Herbots
Lieven.Herbots@jessazh.be
Lieven Herbots, MD, PhD
+3211309579
Lieven.Herbots@jessazh.be
Lieven Herbots, MD, PhD, Principal Investigator
Hartcentrum Hasselt