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

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

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

Conditions
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Covid19, Hemodynamic Instability, ARDS, Human

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Description Group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, hemodynamic monitoring, ARDS