Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Description Group 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Continuous renal replacement therapies [5 days]
Start and end date/time, dialyzing flow, replacement flow, daily balance.
- 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
- Corticoid treatment. [5 days]
Start and end date/time
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 18 years old.
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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).
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Patients admitted to ICU.
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Presence of Kirby index (PaFi) less than or equal to 300 mm Hg, with PEEP or CPAP greater than or equal to 5 cmH2O.
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Need for radial artery cannulation for hemodynamic monitoring and/or repeated monitoring of blood gases at the discretion of the responsible physician.
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Patients who agree (or a representative of the patient if sedated) to participate in study and who provide written informed consent.
Exclusion Criteria:
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Patients being treated with veno-venous or veno-arterial ECMO
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Patient with therapeutic restrictions due to life support
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Patient who presents a complication that requires surgical intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1. A.H. Juan Ramón Jiménez. | Huelva | Andalucia | Spain | 21005 |
| 2 | 5. Hospital Virgen de la Victoria | Málaga | Andalucía | Spain | |
| 3 | 3. Hospital Universitario. Jerez de la Frontera. | Jerez De La Frontera | Cádiz | Spain | |
| 4 | 4. Hospital Universitario de Álava. | Alava | País Vasco | Spain | |
| 5 | 2. Hospital Universitario Infanta Leonor | Madrid | Spain |
Sponsors and Collaborators
- Juan Victor Lorente
- Edwards Lifesciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FAB-HEM-2020-01