Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia

Last updated: May 28, 2024
Sponsor: University Hospital, Strasbourg, France
Overall Status: Terminated

Phase

3

Condition

Lung Injury

Covid-19

Lung Disease

Treatment

Control

Lidocaine 2%

Clinical Study ID

NCT04609865
7820
  • Ages > 18
  • All Genders

Study Summary

The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia.

Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Hospitalized in ICU

  • Presence of all of the following conditions, within one week of a clinical insult ornew or worsening respiratory symptoms:

  • PaO2/FiO2 <300 mmHg with positive end-expiratory pressure (PEEP) ≥5 cmH2O

  • Bilateral opacities not fully explained by cardiac failure or fluid overload

  • Intubated and sedated for mechanical protective ventilation

  • Affiliation to the French Sociale security

  • Beta HCG negative for women

For Covid-19 subgroup:

  • Covid-19 infection (RT-PCR < 7 days and/or another approved diagnostic techniqueand/or typical CT appearance of COVID-19 pneumonia

Exclusion

Exclusion Criteria:

  • Allergy to amide local anesthetics

  • Acute porphyria

  • Disorders of atrioventricular conduction requiring a non-done permanentelectrosystolic pacing

  • Uncontrolled epilepsy

  • Fluvoxamine treatment

  • Class III antiarrythmic agent treatments (amiodarone, dronedarone)

  • Class I antiarythmic agent (quinidine, disopyramide, hydroquinidine, flecainid,propafenone)

  • Hepatocellular insufficiency defined by PT<15% in the absence of anti-vitamin K

  • Patient under a tutelage measure or placed under judicial protection

  • Known pregnancy

  • Breastfeeding

Study Design

Total Participants: 14
Treatment Group(s): 2
Primary Treatment: Control
Phase: 3
Study Start date:
November 04, 2020
Estimated Completion Date:
March 17, 2022

Connect with a study center

  • University Hospital of Hautepierre

    Strasbourg, Bas-Rhin 67000
    France

    Site Not Available

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