Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19

NCT ID: NCT04556864

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-04-01

Brief Summary

The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection

Conditions

Covid19; Hemodynamic Instability; ARDS, Human

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Description Group

• For each patient included in the study, the secondary variables will be noted in the patient's data collection logbook.
• This is followed by radial artery cannulation (if absent), and connection to the HemoSphere/EV1000 platform
• After the daily visit, the PI/collaborating investigators (CI) will measure the clinical, treatment, and mechanical ventilation parameters of the patient during the last 24 hours.
• Daily arterial analysis will be requested
• This information collection process will be followed for 5 days. At the end of the information collection period, the IP will perform two downloads, the engineering download, and the standard download in which the values are monitored every 20 seconds.
• These will be noted in the secondary variables of the data collection logbook, along with the patients' ICU discharge date.
• In-hospital mortality will be monitored during admission to a conventional hospital ward.
• Records will be closed upon discharge of the patient.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years old.
• Patients that are classified as a "confirmed case" according to criteria established by the Spanish Ministry of Health in its Technical Document updated on March 31, 2020. This defines a "confirmed case" as a case that meets laboratory criteria (Positive PCR test for any of the SARS-CoV-2 genes).
• Patients admitted to ICU.
• Presence of Kirby index (PaFi) less than or equal to 300 mm Hg, with PEEP or CPAP greater than or equal to 5 cmH2O.
• Need for radial artery cannulation for hemodynamic monitoring and/or repeated monitoring of blood gases at the discretion of the responsible physician.
• Patients who agree (or a representative of the patient if sedated) to participate in study and who provide written informed consent.

Exclusion Criteria

• Patients being treated with veno-venous or veno-arterial ECMO
• Patient with therapeutic restrictions due to life support
• Patient who presents a complication that requires surgical intervention.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Juan Victor Lorente

OTHER

Sponsor Role: lead

Responsible Party

Juan Victor Lorente

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

1. A.H. Juan Ramón Jiménez.

Huelva, Andalusia, Spain

5. Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

4. Hospital Universitario de Álava.

Alava, Basque Country, Spain

3. Hospital Universitario. Jerez de la Frontera.

Jerez de la Frontera, Cádiz, Spain

2. Hospital Universitario Infanta Leonor

Madrid, , Spain

Countries

Spain

Central Contacts

Juan Victor Lorente, MD

Role: CONTACT

juanvictor.lorente@gmail.com

695881448

Facility Contacts

Juan Victor Lorente, MD

Role: primary

Francisco Cota Delgado, MD

Role: primary

Francisco Javier Maynar, MD

Role: primary

Manuel Ignacio Monge García, MD

Role: primary

Javier Ripollés-Melchor, MD

Role: primary

Other Identifiers

FAB-HEM-2020-01

Identifier Type: -

Identifier Source: org_study_id