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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2022-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine 2%

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No