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

NCT04556864 | Unknown

• 1 other identifier: FAB-HEM-2020-01
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 5

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

Keywords

COVID; hemodynamic monitoring; ARDS

Outcome Measures

Primary Outcomes (1)

• Total amount of hypotension

  Hypotension will be defined as a hemodynamic event that occurs when the MAP falls below 65 mmHg for a minimum duration of 1 minute (3 consecutive recordings of 1 minute or more between two consecutive falls of the MAP).

  5 days

Secondary Outcomes (15)

• Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume)

  5 days

• Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume variation)

  5 days

• Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Cardiac index)

  5 days

• Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor ( HPI)

  5 days

• Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Eadyn)

  5 days

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

Patients with ARDS secondary to SARS-CoV-2 infection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan Victor Lorente: lead
• Edwards Lifesciences: collaborator

Study Sites (5)

1. A.H. Juan Ramón Jiménez.

Huelva, Andalusia, 21005, Spain

Location

5. Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

Location

4. Hospital Universitario de Álava.

Alava, Basque Country, Spain

Location

3. Hospital Universitario. Jerez de la Frontera.

Jerez de la Frontera, Cádiz, Spain

Location

2. Hospital Universitario Infanta Leonor

Madrid, Spain

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

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; Respiration Disorders

Central Study Contacts

Juan Victor Lorente, MD

CONTACT

695881448; juanvictor.lorente@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 21, 2020
• Study Start: October 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: April 1, 2021
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

ES (5)