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.
Drug: Lidocaine 2%
the lidocaine infusion protocol is a bolus of 1 mg/kg (ideal weight), followed by 3mg/kg/h for the first hour, 1.5 mg/kg/h for the second hour, 0.72 mg/kg/h for the next 22 hours, and then 0.6mg/kg/h for 14 days or until extubation.
Drug: Control
The NaCl 0,9% infusion protocol is a bolus of 0.05 ml/kg (ideal weight), followed by 0.15 ml/kg/h for the first hour, 0.075 ml/kg/h for the second hour, 0.36 ml/kg/h for the next 22 hours, and then 0.03 ml/kg/h for 14 days or until extubation.
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
University Hospital of Hautepierre
Strasbourg, Bas-Rhin, France
Investigator: Thiên-Nga CHAMARAUX-TRAN, MD
Contact: 3 88 12 70 81
thiennga.chamaraux-tran@chru-strasbourg.fr
Thiên-Nga CHAMARAUX-TRAN, MD
3 88 12 70 81 - 0033
thiennga.chamaraux-tran@chru-strasbourg.fr