Clinical trial NCT04609865: Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
Official title: Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Respiratory Distress Syndrome (ARDS)
COVID-19
Corona Virus Infection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Breastfeeding

Primary outcomes:
measure: alveolar-capillary gas exchange after two days of treatment
timeFrame: At 48 hours after the first treatment administration
Secondary outcomes:
measure: alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care
timeFrame: From day 0 to day 21 or until coming out of intensive care
measure: Ventilator-free days
timeFrame: At day 28 and at day 90
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : CRP
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : LDH
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Antithrombotic activity of Intravenous Lidocaine on platelets
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Antithrombotic activity of Intravenous Lidocaine on ACT ratio
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Antithrombotic activity of Intravenous Lidocaine on fibrinogen
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Antithrombotic activity of Intravenous Lidocaine on D-Dimers
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Antithrombotic activity of Intravenous Lidocaine on TEG
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Antithrombotic activity of Intravenous Lidocaine on thromboembolic events
timeFrame: At Day 0, day 2, day 7, day 14 and at day 21
measure: Plasma concentration of albumin and Lidocaine
timeFrame: 4 hours after first administration, at day 2, day 7, day 14 and at day 21
measure: Search for hemodynamic dysfynction: Blood pressure measurement in mmHg
timeFrame: daily from day one to day 14
measure: Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed
timeFrame: daily from day one to day 14
measure: Search for hemodynamic dysfynction: Sinus rythm will be assessed
timeFrame: daily from day one to day 14
measure: Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported
timeFrame: daily from day one to day 14
measure: Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured
timeFrame: daily from day one to day 14
measure: ICU ileus: laxation response
timeFrame: daily from Day 0 to Day 28
measure: Opioids, sedative and curare sparing effect (drugs dosage)
timeFrame: daily from Day 0 to Day 28
measure: Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation
timeFrame: From Day0 to Day28 and at Day90
measure: Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay
timeFrame: From Day0 to Day28 and at Day90
measure: Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications
timeFrame: From Day0 to Day28 and at Day90
measure: Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)
timeFrame: extubation day
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital of Hautepierre
state: Bas-Rhin
Study officials:
References:
citation: Muller M, Lefebvre F, Harlay ML, Glady L, Becker G, Muller C, Aberkane O, Tawk M, Julians M, Romoli A, Hecketsweiler S, Schneider F, Pottecher J, Chamaraux-Tran TN. Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 11;22(1):131. doi: 10.1186/s13063-021-05095-x.