search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lidocaine 2%
Control
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome (ARDS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of HautepierreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine 2%

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

alveolar-capillary gas exchange after two days of treatment
PaO2/FiO2 ratio

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 23, 2020
Last Updated
August 17, 2022
Sponsor
University Hospital, Strasbourg, France
search

1. Study Identification

Unique Protocol Identification Number
NCT04609865
Brief Title
Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
Acronym
LidoCovid
Official Title
Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome (ARDS), COVID-19, Corona Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine 2%
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Lidocaine 2%
Intervention Description
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 Type
Drug
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
alveolar-capillary gas exchange after two days of treatment
Description
PaO2/FiO2 ratio
Time Frame
At 48 hours after the first treatment administration
Secondary Outcome Measure Information:
Title
alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care
Description
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
Title
Ventilator-free days
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : CRP
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : LDH
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides
Description
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
Title
Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count
Description
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
Title
Antithrombotic activity of Intravenous Lidocaine on platelets
Description
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
Title
Antithrombotic activity of Intravenous Lidocaine on ACT ratio
Description
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
Title
Antithrombotic activity of Intravenous Lidocaine on fibrinogen
Description
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
Title
Antithrombotic activity of Intravenous Lidocaine on D-Dimers
Description
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
Title
Antithrombotic activity of Intravenous Lidocaine on TEG
Description
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
Title
Antithrombotic activity of Intravenous Lidocaine on thromboembolic events
Description
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
Title
Plasma concentration of albumin and Lidocaine
Description
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
Title
Search for hemodynamic dysfynction: Blood pressure measurement in mmHg
Description
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
Title
Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed
Description
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
Title
Search for hemodynamic dysfynction: Sinus rythm will be assessed
Description
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
Title
Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported
Description
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
Title
Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured
Description
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
Title
ICU ileus: laxation response
Description
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
Title
Opioids, sedative and curare sparing effect (drugs dosage)
Description
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
Title
Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation
Description
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
Title
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay
Description
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
Title
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications
Description
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
Title
Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thiên-Nga CHAMARAUX-TRAN, MD
Phone
3 88 12 70 81
Ext
0033
Email
thiennga.chamaraux-tran@chru-strasbourg.fr
Facility Information:
Facility Name
University Hospital of Hautepierre
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiên-Nga CHAMARAUX-TRAN, MD
Phone
3 88 12 70 81
Ext
0033
Email
thiennga.chamaraux-tran@chru-strasbourg.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
33573681
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs