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Dexmedetomidine to Improve Outcomes of ARDS in Critical Care COVID-19 Patients (COVID-DEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358627
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Clinic of Barcelona

Brief 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. 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

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Inflammation Dexmedetomidine Cytokine Storm Delirium, Emergence Drug: Dexmedetomidine Injectable Product

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020


Group/Cohort Intervention/treatment
DEXMEDETOMIDINE
Patients receiving dexmedetomidine continuous infusion since their admittance to ICU. Continuous checking of the primary and secondary outcomes
Drug: Dexmedetomidine Injectable Product
continuous intravenous infusion of dexmedetomidine
Other Name: DEX IV Sedation

No-DEXMEDETOMIDINE
Historical Control patients matched for ICU admittance diagnosis, age, and concomitant disease and medication state. No Dexmedetomidine. CONtinuous checking of primary outcomes



Primary Outcome Measures :
  1. Mechanical ventilation [ Time Frame: expected within first three days (non conclusive due to lack of evidence yet) ]
    (Presence/Absence) requirement of mechanical ventilation


Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: expected within first seven days (non conclusive due to lack of evidence yet) ]
    Duration of mechanical ventilation if it is required (hours from the start)

  2. Delirium on recovery from sedation [ Time Frame: First 24 hours after retiring dexmedetomidine sedation ]
    Delirium criteria as defined in DSM-4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Affected by autoimmune disease
  • Under specific therapy with Monoclonal Antibodies targeting inflammatory mediators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358627


Contacts
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Contact: Pedro L Gambus, PhD MD +34687075332 plgambus@clinic.cat
Contact: Xavier Borrat, PhD MD xborrat@clinic.cat

Sponsors and Collaborators
Hospital Clinic of Barcelona
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Responsible Party: Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04358627    
Other Study ID Numbers: SPEC-M
SPEC-M COVID-19 ( Other Identifier: Internal )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will share with interested researchers under the acceptance of our Ethics Committee

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Delirium
Emergence Delirium
Syndrome
Inflammation
Disease
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Postoperative Complications
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents