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

• Conditions: ARDS, Human; Covid19; Hemodynamic Instability

• Registration Number: NCT04556864
• Lead Sponsor: Juan Victor Lorente

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-12
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21
• Study Start: 2020-10-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total amount of hypotension	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 Outcome Measures

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

Trial Locations

Locations (5)

3. Hospital Universitario. Jerez de la Frontera.; 🇪🇸 Jerez De La Frontera, Cádiz, Spain

1. A.H. Juan Ramón Jiménez.; 🇪🇸 Huelva, Andalucia, Spain

5. Hospital Virgen de la Victoria; 🇪🇸 Málaga, Andalucía, Spain

2. Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

4. Hospital Universitario de Álava.; 🇪🇸 Alava, País Vasco, Spain