Acute Respiratory Distress SyndromeCOVID-DEXNCT04358627
Dexmedetomidine to Improve Outcomes of ARDS in Critical Care COVID-19 Patients
An observational study of Acute Respiratory Distress Syndrome and Inflammation, run by Hospital Clinic of Barcelona.
Trial summary
A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Inflammation, Dexmedetomidine
- What is being tested?
- Dexmedetomidine Injectable Product
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 30 Jun 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational study, with no randomization, to evaluate the influence of Dexmedetomidine on the time course of ARDS in patients admitted to the ICU unit because of severe respiratory disease triggered by the SARS-CoV-2 (COVID-19) infection.
Who may be able to join
- Patients with respiratory insufficiency criteria candidates to non-invasive ventilation techniques (high flow oxygen masks, non-invasive mechanical ventilation)
- SpO2 (at FiO2: 0.21) ≤ 93% equivalent to SaO2/FiO2≤442
- PaO2/ FiO2 < 300
- Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph that must not be fully explained by cardiac failure or fluid overload, in the physician's best estimation using available information
Who cannot join
- Affected by autoimmune disease
- Under specific therapy with Monoclonal Antibodies targeting inflammatory mediators
Trial locations and contacts
No sites are listed yet.
Xavier Borrat, PhD MD contact
About this study
Official title: Impact of Dexmedetomidine Infusion on the Time Course and Outcomes of Acute Respiratory Distress Syndrome (ARDS) in Patients Affected by the SARS-CoV-2 (COVID-19) Admitted to Critical Care Unit
A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series
Read the detailed description
It will be an observational study, with no randomization. To evaluate the influence of Dexmedetomidine on the time course of ARDS in patients admitted to the ICU unit because of severe respiratory disease triggered by the SARS-CoV-2 (COVID-19) infection. Patients will be informed and asked to sign an Informed Consent Form.
Dexmedetomidine will be used as a sedative which is its admitted therapeutic indication in our country. Dosing will be according to its sedative properties as recommended by the manufacturer and regulation agencies. The only change is that we will study outcomes that have nothing to do with sedation but with a possible positive effect on the hyper-inflammatory state.
The study will be conducted in accordance with the "Orden SAS/3470/2009, of December 16, 2009. Government of Spain
Recruiting and Sample Size calculation We chose mortality as an endpoint to calculate sample size although our primary outcome is to minimize the requirements of mechanical ventilation. Mortality of patients admitted to the ICU because of SARS-CoV-2 (COVID-19) induced ARDS is 48%. Assuming a p value<0.05 and a power of 80%, to demonstrate a 10% decrease in mortality due to the effects of Dexmedetomidine 156 patients should be studied so there will two groups of 80 patients (cases vs historical controls).
However, due to the specific characteristics and the unknown duration of the pandemic, these numbers might not be definitive
Inclusion and Exclusion Criteria (see section)
Drug administrations Dexmedetomidine continuous intravenous infusion will be administered at 0.15 mcg/kg/h as a start and titrating according to sedative responses up to 1.5 mcg/kg/h (max admitted infusion rate)
Other sedatives (usually propofol and remifentanil) may be administered as per ICU protocol
Monitoring
- Ventilation parameters
- Invasive /non-invasive monitoring according to protocols
- The parasympathetic component of HRV will be estimated online by means of the Anesthesia Nociception Index (ANI, MDoloris Medical Systems, Lille, France).
Patient Management Patient management will be performed according to the clinical protocols of the Critical Care Units of Hospital CLINIC de Barcelona regarding the management of patients admitted to ICU because of the consequences of SARS-CoV-2 virus infection
Data Collection Demographic data including age, weight, gender, height, medical conditions, ICU severity score, SOFA score, medications, hemodynamic support, O2 fraction.
Besides regular protocolized monitoring measures for the purposes of the study it will be required:
- Routine Acid-Base equilibrium
- Routine hemogram
- Daily Citokine levels IL1b, IL6, TNFa, IL8, IL4, IL10
- Monocyte profiling Patient data will be kept anonymous except for the IP.
Outcomes to be measured are reported in their respective section
Data Analysis Analysis of the data collected includes the comparison of "primary and secondary outcomes data" acquired to a matched "historical control" with the same severity of ARDS from another COVID-19 + ICU patient with no administration of Dexmedetomidine. A "p" value less than 0.05 will be considered significant in the comparisons with the values of the "historical cohort".
Parametric or non-parametric statistical tests will be used to compare data from the control and study groups, depending on the distribution of such data.
Analysis of the time course of the mediators of inflammation sampled in the first 25 patients will be studied as changes from baseline. Mathematical models of the probability of each one or many of them to be associated with the outcomes of the study will be generated if possible
- Conditions
- Acute Respiratory Distress Syndrome, Inflammation, Dexmedetomidine, Cytokine Storm, Delirium, Emergence
- Being tested
- Dexmedetomidine Injectable Product
- Medical subject headings
- Respiratory Distress Syndrome, Inflammation, Cytokine Release Syndrome, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injectable ProductDrug
Also called DEX IV Sedation
continuous intravenous infusion of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| DEXMEDETOMIDINE | Patients receiving dexmedetomidine continuous infusion since their admittance to ICU. Continuous checking of the primary and secondary outcomes Receives: Drug: Dexmedetomidine Injectable Product | |
| No-DEXMEDETOMIDINE | Historical Control patients matched for ICU admittance diagnosis, age, and concomitant disease and medication state. No Dexmedetomidine. CONtinuous checking of primary outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation
(Presence/Absence) requirement of mechanical ventilation
Measured: expected within first three days (non conclusive due to lack of evidence yet)
Secondary outcomes (2)
Duration of mechanical ventilation
Duration of mechanical ventilation if it is required (hours from the start)
Measured: expected within first seven days (non conclusive due to lack of evidence yet)
Delirium on recovery from sedation
Delirium criteria as defined in DSM-4
Measured: First 24 hours after retiring dexmedetomidine sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358627
- Sponsor's protocol ID
- SPEC-M
- Other IDs
- SPEC-M COVID-19
- Acronym
- COVID-DEX
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share with interested researchers under the acceptance of our Ethics Committee
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine Infusion on the Time Course and Outcomes of Acute Respiratory Distress Syndrome (ARDS) in Patients Affected by the SARS-CoV-2 (COVID-19) Admitted to Critical Care Unit
- ClinicalTrials.gov ID
- NCT04358627
- Acronym / sponsor ID
- COVID-DEX / SPEC-M
- Conditions
- Acute Respiratory Distress Syndrome, Inflammation, Dexmedetomidine, Cytokine Storm, Delirium, Emergence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 24 Apr 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.
A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series
Detailed description
It will be an observational study, with no randomization. To evaluate the influence of Dexmedetomidine on the time course of ARDS in patients admitted to the ICU unit because of severe respiratory disease triggered by the SARS-CoV-2 (COVID-19) infection. Patients will be informed and asked to sign an Informed Consent Form.
Dexmedetomidine will be used as a sedative which is its admitted therapeutic indication in our country. Dosing will be according to its sedative properties as recommended by the manufacturer and regulation agencies. The only change is that we will study outcomes that have nothing to do with sedation but with a possible positive effect on the hyper-inflammatory state.
The study will be conducted in accordance with the "Orden SAS/3470/2009, of December 16, 2009. Government of Spain
Recruiting and Sample Size calculation We chose mortality as an endpoint to calculate sample size although our primary outcome is to minimize the requirements of mechanical ventilation. Mortality of patients admitted to the ICU because of SARS-CoV-2 (COVID-19) induced ARDS is 48%. Assuming a p value<0.05 and a power of 80%, to demonstrate a 10% decrease in mortality due to the effects of Dexmedetomidine 156 patients should be studied so there will two groups of 80 patients (cases vs historical controls).
However, due to the specific characteristics and the unknown duration of the pandemic, these numbers might not be definitive
Inclusion and Exclusion Criteria (see section)
Drug administrations Dexmedetomidine continuous intravenous infusion will be administered at 0.15 mcg/kg/h as a start and titrating according to sedative responses up to 1.5 mcg/kg/h (max admitted infusion rate)
Other sedatives (usually propofol and remifentanil) may be administered as per ICU protocol
Monitoring
- Ventilation parameters
- Invasive /non-invasive monitoring according to protocols
- The parasympathetic component of HRV will be estimated online by means of the Anesthesia Nociception Index (ANI, MDoloris Medical Systems, Lille, France).
Patient Management Patient management will be performed according to the clinical protocols of the Critical Care Units of Hospital CLINIC de Barcelona regarding the management of patients admitted to ICU because of the consequences of SARS-CoV-2 virus infection
Data Collection Demographic data including age, weight, gender, height, medical conditions, ICU severity score, SOFA score, medications, hemodynamic support, O2 fraction.
Besides regular protocolized monitoring measures for the purposes of the study it will be required:
- Routine Acid-Base equilibrium
- Routine hemogram
- Daily Citokine levels IL1b, IL6, TNFa, IL8, IL4, IL10
- Monocyte profiling Patient data will be kept anonymous except for the IP.
Outcomes to be measured are reported in their respective section
Data Analysis Analysis of the data collected includes the comparison of "primary and secondary outcomes data" acquired to a matched "historical control" with the same severity of ARDS from another COVID-19 + ICU patient with no administration of Dexmedetomidine. A "p" value less than 0.05 will be considered significant in the comparisons with the values of the "historical cohort".
Parametric or non-parametric statistical tests will be used to compare data from the control and study groups, depending on the distribution of such data.
Analysis of the time course of the mediators of inflammation sampled in the first 25 patients will be studied as changes from baseline. Mathematical models of the probability of each one or many of them to be associated with the outcomes of the study will be generated if possible
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEXMEDETOMIDINE | – | Drug: Dexmedetomidine Injectable ProductPatients receiving dexmedetomidine continuous infusion since their admittance to ICU. Continuous checking of the primary and secondary outcomes |
| No-DEXMEDETOMIDINE | – | –Historical Control patients matched for ICU admittance diagnosis, age, and concomitant disease and medication state. No Dexmedetomidine. CONtinuous checking of primary outcomes |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational study, with no randomization, to evaluate the influence of Dexmedetomidine on the time course of ARDS in patients admitted to the ICU unit because of severe respiratory disease triggered by the SARS-CoV-2 (COVID-19) infection.
Key inclusion criteria (4 listed)
- Patients with respiratory insufficiency criteria candidates to non-invasive ventilation techniques (high flow oxygen masks, non-invasive mechanical ventilation)
- SpO2 (at FiO2: 0.21) ≤ 93% equivalent to SaO2/FiO2≤442
- PaO2/ FiO2 < 300
- Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph that must not be fully explained by cardiac failure or fluid overload, in the physician's best estimation using available information
Key exclusion criteria (2 listed)
- Affected by autoimmune disease
- Under specific therapy with Monoclonal Antibodies targeting inflammatory mediators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Injectable ProductAlso: DEX IV Sedationcontinuous intravenous infusion of dexmedetomidine | Drug | DEXMEDETOMIDINE |
Primary outcome
Mechanical ventilation
Time frame: expected within first three days (non conclusive due to lack of evidence yet)
(Presence/Absence) requirement of mechanical ventilation
2 secondary outcomes
Duration of mechanical ventilation
Time frame: expected within first seven days (non conclusive due to lack of evidence yet)
Delirium on recovery from sedation
Time frame: First 24 hours after retiring dexmedetomidine sedation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided. We will share with interested researchers under the acceptance of our Ethics Committee
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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.
Xavier Borrat, PhD MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Inflammation, run by Hospital Clinic of Barcelona.
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 4 inclusion and 2 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Pedro L Gambus, PhD MD (+34687075332, plgambus@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation (time frame: expected within first three days (non conclusive due to lack of evidence yet)). 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 24 Apr 2020.