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

Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to SARS-CoV-2 Infection

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

Study Overview

• Status: Unknown
• Conditions: Covid19; ARDS, Human; Hemodynamic Instability

• Study Type: Observational
• Enrollment (Anticipated): 67

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • 2. Hospital Universitario Infanta Leonor
  • Andalucia
    • Huelva, Andalucia, Spain, 21005
      • 1. A.H. Juan Ramón Jiménez.
  • Andalucía
    • Málaga, Andalucía, Spain
      • 5. Hospital Virgen de la Victoria
  • Cádiz
    • Jerez De La Frontera, Cádiz, Spain
      • 3. Hospital Universitario. Jerez de la Frontera.
  • País Vasco
    • Alava, País Vasco, Spain
      • 4. Hospital Universitario de Álava.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ARDS secondary to SARS-CoV-2 infection

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume)	We will obtain hemodynamic data for the first 5 days after the patient enters the study	5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume variation)	We will obtain hemodynamic data for the first 5 days after the patient enters the study	5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Cardiac index)	We will obtain hemodynamic data for the first 5 days after the patient enters the study	5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor ( HPI)	We will obtain hemodynamic data for the first 5 days after the patient enters the study	5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Eadyn)	We will obtain hemodynamic data for the first 5 days after the patient enters the study	5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (dp/dt max,)	We will obtain hemodynamic data for the first 5 days after the patient enters the study	5 days
Presence of treatment with noradrenaline; presence of treatment with dobutamine, presence of treatment with other vasoactive/ionotropic/hypotensive drugs	start time, time of dose change, current dose	5 days
Furosemide treatment	dose/24 hours	Daily during 5 days
Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.	ml/24 h	Daily during 5 days
Atrial fibrillation	Presence, start time and end time	5 days
Acute kidney injury	Presence and degree with KDIGO definition	Daily during 5 days
Continuous renal replacement therapies	Start and end date/time, dialyzing flow, replacement flow, daily balance.	5 days
Need for Hemadsorption	Start and end date/time, blood flow.	5 days
Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)	Start and end date/time	5 days
Corticoid treatment.	Start and end date/time	5 days

Collaborators and Investigators

• Sponsor: Juan Victor Lorente
• Collaborators: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: September 12, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: ARDS; COVID; hemodynamic monitoring
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Distress Syndrome
• Other Study ID Numbers: FAB-HEM-2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No