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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04556864
• Other study ID #: FAB-HEM-2020-01
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2020
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: Juan Victor Lorente, MD
• Phone: 695881448
• Email: juanvictor.lorente[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: April 1, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS, Human
• Covid19
• Hemodynamic Instability
• Respiratory Distress Syndrome, Adult

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Juan Victor Lorente	Edwards Lifesciences

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Furosemide treatment	dose/24 hours	Daily during 5 days
Secondary	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
Secondary	Atrial fibrillation	Presence, start time and end time	5 days
Secondary	Acute kidney injury	Presence and degree with KDIGO definition	Daily during 5 days
Secondary	Continuous renal replacement therapies	Start and end date/time, dialyzing flow, replacement flow, daily balance.	5 days
Secondary	Need for Hemadsorption	Start and end date/time, blood flow.	5 days
Secondary	Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)	Start and end date/time	5 days
Secondary	Corticoid treatment.	Start and end date/time	5 days