Covid19NCT04556864
Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19
An observational study of Covid19 and Hemodynamic Instability, run by Juan Victor Lorente at 5 sites in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hemodynamic Instability, ARDS, Human
- How many people
- 67 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Oct 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ARDS secondary to SARS-CoV-2 infection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
4. Hospital Universitario de Álava.
Alava, Basque Country
Francisco Javier Maynar, MD
1. A.H. Juan Ramón Jiménez.
Huelva, Andalusia, 21005
Juan Victor Lorente, MD
Juan Victor Lorente, MD
3. Hospital Universitario. Jerez de la Frontera.
Jerez de la Frontera, Cádiz
Manuel Ignacio Monge García, MD
2. Hospital Universitario Infanta Leonor
Madrid
Javier Ripollés-Melchor, MD
5. Hospital Virgen de la Victoria
Málaga, Andalusia
Francisco Cota Delgado, MD
About this study
Official title: Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to SARS-CoV-2 Infection
The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection
- Conditions
- Covid19, Hemodynamic Instability, ARDS, Human
- Keywords
- COVID, hemodynamic monitoring, ARDS
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
Secondary outcomes (15)
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
Measured: 5 days
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
Measured: 5 days
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
Measured: 5 days
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
Measured: 5 days
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
Measured: 5 days
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
Measured: 5 days
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
Measured: 5 days
Furosemide treatment
dose/24 hours
Measured: Daily during 5 days
Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.
ml/24 h
Measured: Daily during 5 days
Atrial fibrillation
Presence, start time and end time
Measured: 5 days
Acute kidney injury
Presence and degree with KDIGO definition
Measured: Daily during 5 days
Continuous renal replacement therapies
Start and end date/time, dialyzing flow, replacement flow, daily balance.
Measured: 5 days
Need for Hemadsorption
Start and end date/time, blood flow.
Measured: 5 days
Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)
Start and end date/time
Measured: 5 days
Corticoid treatment.
Start and end date/time
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Victor Lorente
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor-investigator, Juan Victor Lorente, Andalusian Network for Design and Translation of Advanced Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556864
- Sponsor's protocol ID
- FAB-HEM-2020-01
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04556864
- Acronym / sponsor ID
- FAB-HEM-2020-01
- Conditions
- Covid19, Hemodynamic Instability, ARDS, Human
- Keywords
- COVID, hemodynamic monitoring, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Juan Victor LorenteUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS secondary to SARS-CoV-2 infection
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
15 secondary outcomes
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume)
Time frame: 5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume variation)
Time frame: 5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Cardiac index)
Time frame: 5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor ( HPI)
Time frame: 5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Eadyn)
Time frame: 5 days
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (dp/dt max,)
Time frame: 5 days
Presence of treatment with noradrenaline; presence of treatment with dobutamine, presence of treatment with other vasoactive/ionotropic/hypotensive drugs
Time frame: 5 days
Furosemide treatment
Time frame: Daily during 5 days
Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.
Time frame: Daily during 5 days
Atrial fibrillation
Time frame: 5 days
Acute kidney injury
Time frame: Daily during 5 days
Continuous renal replacement therapies
Time frame: 5 days
Need for Hemadsorption
Time frame: 5 days
Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)
Time frame: 5 days
Corticoid treatment.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hemodynamic Instability, run by Juan Victor Lorente at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Victor Lorente, MD (695881448, juanvictor.lorente@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of hypotension (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.