A Phase 3 interventional study of Lidocaine 2% and Control in Acute Respiratory Distress Syndrome (ARDS), COVID-19 and Corona Virus Infection, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by University Hospital, Strasbourg, France · Phase 3, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For Covid-19 subgroup:
Exclusion Criteria:
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: Lidocaine 2%
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.
Drug: Control
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.
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.
alveolar-capillary gas exchange after two days of treatment
PaO2/FiO2 ratio
Time frame: At 48 hours after the first treatment administration
alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care
PaO2/FiO2 ratio : a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: From day 0 to day 21 or until coming out of intensive care
Ventilator-free days
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At day 28 and at day 90
Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : CRP
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : LDH
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: 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
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on platelets
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on ACT ratio
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on fibrinogen
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on D-Dimers
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on TEG
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on thromboembolic events
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Plasma concentration of albumin and Lidocaine
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: 4 hours after first administration, at day 2, day 7, day 14 and at day 21
Search for hemodynamic dysfynction: Blood pressure measurement in mmHg
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Blood pressure in mmHg will be measured
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Cardiac frequency in beats per minute will be assessed
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: Sinus rythm will be assessed
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Sinus rythm will be assessed
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Vasopressors and inotropes drugs use will be reported
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. EKG : PR, QRS, QTc intervals in ms will be measured
Time frame: daily from day one to day 14
ICU ileus: laxation response
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: daily from Day 0 to Day 28
Opioids, sedative and curare sparing effect (drugs dosage)
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: daily from Day 0 to Day 28
Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: From Day0 to Day28 and at Day90
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: From Day0 to Day28 and at Day90
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: From Day0 to Day28 and at Day90
Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Time frame: extubation day
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France