Covid-19COVID-HONCT04371679
Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients
An observational study of Covid-19, run by Hasselt University at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive COVID-19 positive patients that are admitted to the ICU
Who may be able to join
- 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, …)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, 3500
Lieven Herbots, Lieven.Herbots@jessazh.be
About this study
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.
Read the 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
- Conditions
- Covid-19
- Being tested
- No interventions planned
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions plannedOther
No interventions planned. Observational.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal intubation and ventilation | Patients admitted at ICU that are intubated and ventilated Receives: Other: No interventions planned | |
| Non-Invasive Ventilation | Patients admitted at ICU who are non-invasively ventilated Receives: Other: No interventions planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death (all-cause mortality) or discharge from ICU (limit of 4 months)
Covid-19 pneumonia that requires ICU admission can go either way.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Apr 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Lieven Herbots, MD, PhD, Principal investigator, Hartcentrum Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371679
- Sponsor's protocol ID
- Covid-HO
- Acronym
- COVID-HO
- Status last verified
- Mar 2022
- First submitted
- 30 Apr 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04371679
- Acronym / sponsor ID
- COVID-HO / Covid-HO
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation and ventilation | – | Other: No interventions plannedPatients admitted at ICU that are intubated and ventilated |
| Non-Invasive Ventilation | – | Other: No interventions plannedPatients admitted at ICU who are non-invasively ventilated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive COVID-19 positive patients that are admitted to the ICU
Key inclusion criteria (4 listed)
- 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, …)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions plannedNo interventions planned. Observational. | Other | Endotracheal intubation and ventilation, Non-Invasive Ventilation |
Primary outcome
Death (all-cause mortality) or discharge from ICU (limit of 4 months)
Time frame: 4 months
Covid-19 pneumonia that requires ICU admission can go either way.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven Herbots, MD, PhD principal investigator
Hartcentrum Hasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lieven Herbots, MD, PhD (+3211309579, Lieven.Herbots@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (all-cause mortality) or discharge from ICU (limit of 4 months) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.