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

NCT04371679 | Unknown

• 1 other identifier: Covid-HO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Endotracheal intubation and ventilation

Patients admitted at ICU that are intubated and ventilated

Other: No interventions planned

Non-Invasive Ventilation

Patients admitted at ICU who are non-invasively ventilated

Other: No interventions planned

Interventions

No interventions planned OTHER

No interventions planned. Observational.

Endotracheal intubation and ventilation; Non-Invasive Ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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, …)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lieven Herbots, MD, PhD

  Hartcentrum Hasselt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven Herbots, MD, PhD

CONTACT

+3211309579; Lieven.Herbots@jessazh.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 1, 2020
• Study Start: April 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)