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

University Hospital, Strasbourg, France1 site in 1 country14 target enrollmentNovember 4, 2020

ConditionsAcute Respiratory Distress Syndrome (ARDS)COVID-19 Corona Virus Infection

InterventionsLidocaine 2%Control

Overview

Phase: Phase 3
Intervention: Lidocaine 2%
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Sponsor: University Hospital, Strasbourg, France
Enrollment: 14
Locations: 1
Primary Endpoint: alveolar-capillary gas exchange after two days of treatment
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 4, 2020

End Date

March 17, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Strasbourg, France

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

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.

Intervention: Lidocaine 2%

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.

Intervention: Control

Outcomes

Primary Outcomes

alveolar-capillary gas exchange after two days of treatment

Time Frame: At 48 hours after the first treatment administration

PaO2/FiO2 ratio

Secondary Outcomes

Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates(At Day 0, day 2, day 7, day 14 and at day 21)
Measure the effects of Intravenous Lidocaine on Biomarkers : CRP(At Day 0, day 2, day 7, day 14 and at day 21)
Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count(At Day 0, day 2, day 7, day 14 and at day 21)
Antithrombotic activity of Intravenous Lidocaine on fibrinogen(At Day 0, day 2, day 7, day 14 and at day 21)
Antithrombotic activity of Intravenous Lidocaine on thromboembolic events(At Day 0, day 2, day 7, day 14 and at day 21)
Ventilator-free days(At day 28 and at day 90)
Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin(At Day 0, day 2, day 7, day 14 and at day 21)
Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported(daily from day one to day 14)
Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS(At Day 0, day 2, day 7, day 14 and at day 21)
alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care(From day 0 to day 21 or until coming out of intensive care)
Measure the effects of Intravenous Lidocaine on Biomarkers : LDH(At Day 0, day 2, day 7, day 14 and at day 21)
Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6(At Day 0, day 2, day 7, day 14 and at day 21)
Antithrombotic activity of Intravenous Lidocaine on platelets(At Day 0, day 2, day 7, day 14 and at day 21)
Search for hemodynamic dysfynction: Blood pressure measurement in mmHg(daily from day one to day 14)
Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed(daily from day one to day 14)
Opioids, sedative and curare sparing effect (drugs dosage)(daily from Day 0 to Day 28)
Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation(From Day0 to Day28 and at Day90)
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications(From Day0 to Day28 and at Day90)
Antithrombotic activity of Intravenous Lidocaine on D-Dimers(At Day 0, day 2, day 7, day 14 and at day 21)
Antithrombotic activity of Intravenous Lidocaine on TEG(At Day 0, day 2, day 7, day 14 and at day 21)
Plasma concentration of albumin and Lidocaine(4 hours after first administration, at day 2, day 7, day 14 and at day 21)
ICU ileus: laxation response(daily from Day 0 to Day 28)
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay(From Day0 to Day28 and at Day90)
Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured(daily from day one to day 14)
Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides(At Day 0, day 2, day 7, day 14 and at day 21)
Antithrombotic activity of Intravenous Lidocaine on ACT ratio(At Day 0, day 2, day 7, day 14 and at day 21)
Search for hemodynamic dysfynction: Sinus rythm will be assessed(daily from day one to day 14)
Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)(extubation day)