Clinical trial NCT04556864: Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19
Official title: Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Hemodynamic Instability
ARDS, Human
Keywords: COVID
hemodynamic monitoring
ARDS
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2020-09-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ARDS secondary to SARS-CoV-2 infection

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


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.

Primary outcomes:
measure: Total amount of hypotension
timeFrame: 5 days
Secondary outcomes:
measure: Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume)
timeFrame: 5 days
measure: Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume variation)
timeFrame: 5 days
measure: Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Cardiac index)
timeFrame: 5 days
measure: Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor ( HPI)
timeFrame: 5 days
measure: Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Eadyn)
timeFrame: 5 days
measure: Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (dp/dt max,)
timeFrame: 5 days
measure: Presence of treatment with noradrenaline; presence of treatment with dobutamine, presence of treatment with other vasoactive/ionotropic/hypotensive drugs
timeFrame: 5 days
measure: Furosemide treatment
timeFrame: Daily during 5 days
measure: Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.
timeFrame: Daily during 5 days
measure: Atrial fibrillation
timeFrame: 5 days
measure: Acute kidney injury
timeFrame: Daily during 5 days
measure: Continuous renal replacement therapies
timeFrame: 5 days
measure: Need for Hemadsorption
timeFrame: 5 days
measure: Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)
timeFrame: 5 days
measure: Corticoid treatment.
timeFrame: 5 days
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: 1. A.H. Juan Ramón Jiménez.
state: Andalucia
city: Málaga
country: Spain
facility: 5. Hospital Virgen de la Victoria
state: Andalucía
city: Jerez De La Frontera
country: Spain
facility: 3. Hospital Universitario. Jerez de la Frontera.
state: Cádiz
city: Alava
country: Spain
facility: 4. Hospital Universitario de Álava.
state: País Vasco
city: Madrid
country: Spain
facility: 2. Hospital Universitario Infanta Leonor
Study officials:
References: