Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients (COVID-HO)

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.

Study Overview

• Status: Recruiting
• Conditions: Covid-19
• Intervention / Treatment: Other: No interventions planned

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Lieven Herbots, MD, PhD; Phone Number: +3211309579; Email: Lieven.Herbots@jessazh.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Hospital
    • Contact: Lieven Herbots; Email: Lieven.Herbots@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive COVID-19 positive patients that are admitted to the ICU

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endotracheal intubation and ventilation; Patients admitted at ICU that are intubated and ventilated	Other: No interventions planned; No interventions planned. Observational.
Non-Invasive Ventilation; Patients admitted at ICU who are non-invasively ventilated	Other: No interventions planned; No interventions planned. Observational.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death (all-cause mortality) or discharge from ICU (limit of 4 months)	Covid-19 pneumonia that requires ICU admission can go either way.	4 months

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Lieven Herbots, MD, PhD, Hartcentrum Hasselt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Covid-HO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No