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

• Status: Recruiting
• Trial end date: 2024-02-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Age ≥18 years

• Hospitalized in ICU

• Presence of all of the following conditions, within one week of a clinical insult or new 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 technique and/or typical CT appearance of COVID-19 pneumonia

Exclusion Criteria:

• Allergy to amide local anesthetics

• Acute porphyria

• Disorders of atrioventricular conduction requiring a non-done permanent electrosystolic 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