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

NCT04358627 | Unknown FDA Drug

• 2 other identifiers: SPEC-MSPEC-M COVID-19
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Respiratory Distress Syndrome; Inflammation; Dexmedetomidine; Cytokine Storm; Delirium, Emergence

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation

  (Presence/Absence) requirement of mechanical ventilation

  expected within first three days (non conclusive due to lack of evidence yet)

Secondary Outcomes (2)

• Duration of mechanical ventilation

  expected within first seven days (non conclusive due to lack of evidence yet)

• Delirium on recovery from sedation

  First 24 hours after retiring dexmedetomidine sedation

Study Arms (2)

DEXMEDETOMIDINE

Patients receiving dexmedetomidine continuous infusion since their admittance to ICU. Continuous checking of the primary and secondary outcomes

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

Interventions

Dexmedetomidine Injectable Product DRUG

continuous intravenous infusion of dexmedetomidine

Also known as: DEX IV Sedation

DEXMEDETOMIDINE

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Inflammation; Cytokine Release Syndrome; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Shock; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Pedro L Gambus, PhD MD

CONTACT

+34687075332; plgambus@clinic.cat

Xavier Borrat, PhD MD

CONTACT

xborrat@clinic.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 24, 2020
• Study Start: April 15, 2020
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04