Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)COVID-19Corona Virus Infection
- Interventions
- Drug: Control
- Registration Number
- NCT04609865
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control 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. Lidocaine 2% 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.
- Primary Outcome Measures
Name Time Method alveolar-capillary gas exchange after two days of treatment At 48 hours after the first treatment administration PaO2/FiO2 ratio
- Secondary Outcome Measures
Name Time Method Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates At Day 0, day 2, day 7, day 14 and at day 21 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.
Measure the effects of Intravenous Lidocaine on Biomarkers : CRP At Day 0, day 2, day 7, day 14 and at day 21 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.
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 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.
Antithrombotic activity of Intravenous Lidocaine on fibrinogen At Day 0, day 2, day 7, day 14 and at day 21 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.
Antithrombotic activity of Intravenous Lidocaine on thromboembolic events At Day 0, day 2, day 7, day 14 and at day 21 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.
Ventilator-free days At day 28 and at day 90 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.
Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin At Day 0, day 2, day 7, day 14 and at day 21 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.
Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported daily from day one to day 14 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 reportedMeasure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS At Day 0, day 2, day 7, day 14 and at day 21 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.
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 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.
Measure the effects of Intravenous Lidocaine on Biomarkers : LDH At Day 0, day 2, day 7, day 14 and at day 21 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.
Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6 At Day 0, day 2, day 7, day 14 and at day 21 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.
Antithrombotic activity of Intravenous Lidocaine on platelets At Day 0, day 2, day 7, day 14 and at day 21 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.
Search for hemodynamic dysfynction: Blood pressure measurement in mmHg daily from day one to day 14 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 measuredSearch for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed daily from day one to day 14 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 assessedOpioids, sedative and curare sparing effect (drugs dosage) daily from Day 0 to Day 28 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.
Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation From Day0 to Day28 and at Day90 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.
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications From Day0 to Day28 and at Day90 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.
Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides At Day 0, day 2, day 7, day 14 and at day 21 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.
Antithrombotic activity of Intravenous Lidocaine on D-Dimers At Day 0, day 2, day 7, day 14 and at day 21 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.
Antithrombotic activity of Intravenous Lidocaine on TEG At Day 0, day 2, day 7, day 14 and at day 21 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.
Plasma concentration of albumin and Lidocaine 4 hours after first administration, at day 2, day 7, day 14 and at day 21 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.
ICU ileus: laxation response daily from Day 0 to Day 28 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.
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay From Day0 to Day28 and at Day90 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.
Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured daily from day one to day 14 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 measuredAntithrombotic activity of Intravenous Lidocaine on ACT ratio At Day 0, day 2, day 7, day 14 and at day 21 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.
Search for hemodynamic dysfynction: Sinus rythm will be assessed daily from day one to day 14 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 assessedCough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy) extubation day 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.
Trial Locations
- Locations (1)
University Hospital of Hautepierre
🇫🇷Strasbourg, Bas-Rhin, France