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
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