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

NCT04609865 | Terminated Phase 3

• 1 other identifier: 7820
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• alveolar-capillary gas exchange after two days of treatment

  PaO2/FiO2 ratio

  At 48 hours after the first treatment administration

Secondary Outcomes (28)

• 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

• Ventilator-free days

  At day 28 and at day 90

• Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin

  At Day 0, day 2, day 7, day 14 and at day 21

• Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates

  At Day 0, day 2, day 7, day 14 and at day 21

• Measure the effects of Intravenous Lidocaine on Biomarkers : CRP

  At Day 0, day 2, day 7, day 14 and at day 21

Study Arms (2)

Lidocaine 2%

EXPERIMENTAL

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%

Control

PLACEBO COMPARATOR

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

Interventions

Lidocaine 2% 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.

Lidocaine 2%

Control 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital of Hautepierre

Strasbourg, Bas-Rhin, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 33573681 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: November 4, 2020
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

FR (1)