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

Juan Victor Lorente5 sites in 1 country67 target enrollmentOctober 1, 2020

ConditionsCovid19 Hemodynamic Instability ARDS, Human

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: Juan Victor Lorente
Enrollment: 67
Locations: 5
Primary Endpoint: Total amount of hypotension
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 1, 2020

End Date

April 1, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Juan Victor Lorente

Responsible Party

Sponsor Investigator

Principal Investigator

Juan Victor Lorente

Medical Doctor

Andalusian Network for Design and Translation of Advanced Therapies

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,
•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.

Outcomes

Primary Outcomes

Total amount of hypotension

Time Frame: 5 days

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).

Secondary Outcomes

Acute kidney injury(Daily during 5 days)
Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.(Daily during 5 days)
Atrial fibrillation(5 days)
Need for Hemadsorption(5 days)
Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)(5 days)
Continuous renal replacement therapies(5 days)
Corticoid treatment.(5 days)
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)
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (dp/dt max,)(5 days)
Presence of treatment with noradrenaline; presence of treatment with dobutamine, presence of treatment with other vasoactive/ionotropic/hypotensive drugs(5 days)
Furosemide treatment(Daily during 5 days)