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

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 3

Conditions: COVID-19; Corona Virus Infection; Acute Respiratory Distress Syndrome (ARDS)

Treatments: Drug: Control; Drug: Lidocaine 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT04609865

7820

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

Lidocaine 2%

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine 2%

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Control