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

COVID-19 Clinical Trial

— LidoCovid  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609865
• Other study ID #: 7820
• Status: Recruiting
• Phase: Phase 3
• Start date: November 4, 2020
• Est. completion date: February 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Strasbourg, France
• Contact: Thiên-Nga CHAMARAUX-TRAN, MD
• Phone: 3 88 12 70 81
• Email: thiennga.chamaraux-tran[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
France	University Hospital of Hautepierre	Strasbourg	Bas-Rhin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alveolar-capillary gas exchange after two days of treatment	PaO2/FiO2 ratio	At 48 hours after the first treatment administration
Secondary	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.	From day 0 to day 21 or until coming out of intensive care
Secondary	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.	At day 28 and at day 90
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	At Day 0, day 2, day 7, day 14 and at day 21
Secondary	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.	4 hours after first administration, at day 2, day 7, day 14 and at day 21
Secondary	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	daily from day one to day 14
Secondary	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	daily from day one to day 14
Secondary	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	daily from day one to day 14
Secondary	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	daily from day one to day 14
Secondary	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	daily from day one to day 14
Secondary	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.	daily from Day 0 to Day 28
Secondary	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.	daily from Day 0 to Day 28
Secondary	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.	From Day0 to Day28 and at Day90
Secondary	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.	From Day0 to Day28 and at Day90
Secondary	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.	From Day0 to Day28 and at Day90
Secondary	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.	extubation day