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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. Read our disclaimer for details. Identifier: NCT04358627
Recruitment Status : Unknown
Verified April 2020 by Hospital Clinic of Barcelona.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
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
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT04358627

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Contact: Pedro L Gambus, PhD MD +34687075332
Contact: Xavier Borrat, PhD MD

Sponsors and Collaborators
Hospital Clinic of Barcelona
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Responsible Party: Hospital Clinic of Barcelona 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
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Emergence Delirium
Cytokine Release Syndrome
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Systemic Inflammatory Response Syndrome
Postoperative Complications
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents