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Zalnieriute, Monika. "Google LLC v. Commission nationale de l'informatique et des libertés (CNIL)." American Journal of International Law 114, no. 2 (April 2020): 261–67. http://dx.doi.org/10.1017/ajil.2020.5.
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In Google LLC v. Commission nationale de l'informatique et des libertés (CNIL), the Court of Justice of the European Union (CJEU or Court) held that the EU law only requires valid “right to be forgotten” de-referencing requests to be carried out by a search engine operator on search engine versions accessible in EU member states, as opposed to all versions of its search engine worldwide. While the ruling has been perceived as a “win” for Google and other interveners, such as Microsoft and the Wikimedia Foundation, who argued against worldwide de-referencing, the Court also made clear that that while the EU law does not currently require worldwide de-referencing, “it also does not prohibit such a practice” (para. 72). As a result, the CJEU found that an order by a national supervisory or judicial authority of an EU member state requiring worldwide de-referencing in accordance with its own national data protection laws would not be inconsistent with EU law where the data subject's right to privacy is adequately balanced against the right to freedom of information. By leaving the door to extraterritorial de-referencing wide open, the CJEU continues to pursue its post-Snowden hard-line stance on data privacy in a manner that is likely to transform the data privacy landscape.
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Truchet, Didier. "La "jurisprudence" de la Commission Nationale de l'Informatique et des Libertés [A propos des normes simplifiées]." Revue Judiciaire de l'Ouest 9, no. 2 (1985): 148–64. http://dx.doi.org/10.3406/juro.1985.1294.
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Propp, Kenneth. "Google LLC v. Commission Nationale de l'Informatique et des Libertés (CNIL) and Eva Glawischnig-Piesczek v. Facebook Ireland Ltd. (C.J.E.U.)." International Legal Materials 59, no. 3 (June 2020): 428–58. http://dx.doi.org/10.1017/ilm.2020.25.
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During the fall of 2019, the European Court of Justice (hereinafter the ECJ or the Court) delivered judgments in two cases addressing the responsibility of internet platform companies for the personal information they control. In Google LLC v. Commission Nationale de l'Informatique et des Libertés (CNIL), the ECJ considered the geographic scope of its notable recent jurisprudence on the obligations of search engines to implement the “right to be forgotten” set forth in European Union (EU) data protection law. In Eva Glawischnig-Piesczek v. Facebook Ireland Limited, the Court examined whether Facebook was obliged under EU law to remove information available on the social network that previously had been found under Austrian law to defame an Austrian politician.
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Karakus, Arif, Nicolas Girerd, Jean-Charles Sanchez, Candice Sabben, Anthony Wietrich, Karine Lavandier, Sophie Marchal, et al. "Identifying patients with cerebral infarction within the time window compatible with reperfusion therapy, diagnostic performance of glutathione S-transferase-π (GST-π) and peroxiredoxin 1 (PRDX1): exploratory prospective multicentre study FLAG-1 protocol." BMJ Open 11, no. 8 (August 2021): e046167. http://dx.doi.org/10.1136/bmjopen-2020-046167.
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IntroductionPlasma biomarkers may be useful in diagnosing acute cerebral infarction requiring urgent reperfusion, but their performance remains to be confirmed. If confirmed, these molecules could be used to develop rapid and reliable decentralised measurement methods, making it possible to initiate reperfusion therapy before hospital admission. The FLAG-1 large prospective study will constitute a plasma bank to assess the diagnostic performance of two biomarkers: glutathione S-transferase-π and peroxiredoxin 1. These molecules are involved in the oxidative stress response and could identify cerebral infarction within a therapeutic window of less than 4.5 hours following the onset of symptoms. Secondary objectives include assessing performance of these biomarkers within 3-hour and 6-hour windows; identifying additional biomarkers diagnosing cerebral infarction and significant criteria guiding therapeutic decisions: ischaemic features of stroke, presence of diffusion/fluid-attenuated inversion recovery mismatch, volume of cerebral infarction and penumbra on cerebral MRI.Methods and analysisThe exploratory, prospective, multicentre FLAG-1 Study will include 945 patients with acute stroke symptoms (onset ≤12 hours, National Institute of Health Stroke Scale score ≥3). Each patient’s 25 mL blood sample will be associated with cerebral MRI data. Two patient groups will be defined based on the time of blood collection (before and after 4.5 hours following onset). Receiver operating characteristic analysis will determine the diagnostic performance of each biomarker, alone or in combination, for the identification of cerebral infarction <4.5 hours.Ethics and disseminationThe protocol has been approved by an independent ethics committee. Biological samples are retained in line with best practices and procedures, in accordance with French legislation. Anonymised data and cerebral imaging records are stored using electronic case report forms and a secure server, respectively, registered with the French Data Protection Authority (Commission Nationale de l'Informatique et des Libertés (CNIL)). Results will be disseminated through scientific meetings and publication in peer-reviewed medical journals.Trial registration numberClinicalTrials.gov Registry (NCT03364296).
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Michallet, Mauricette, Romain Buono, Mohamad Sobh, Solene Poirey, Emmanuelle Nicolas-Virelizier, Souad Assaad, Amine Belhabri, et al. "Study of Treatment Complications in Oncology / Hematology Patients: Protocol for a Prospective and Interventional Cohort Study from the Pasca Program." Blood 136, Supplement 1 (November 5, 2020): 10–11. http://dx.doi.org/10.1182/blood-2020-142355.
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Introduction In France, cancer incidence is increasing, reaching approximately 400,000 new cases in 2017. Thanks to diagnostic and therapeutic advances, net survival at 5 years is improving, with a corollary increase in the number of survivors. Among survivors, 44% have a poor quality of life due to the more or less late onset of treatment-related complications. Despite the objectives of the 2014-2019 national cancer plan considering the latest therapeutic advances, very few initiatives integrating systematic, early detection and management of complications exist in France. Methods and analysis PASCA (Care pathways through cancer) is a single-arm, interdisciplinary, prospective, interventional, cohort study. During a period of 24 months, it is intended to include 858 adults aged 18 to 65 years with non-Hodgkin and Hodgkin lymphoma, acute myeloid leukemia, testicular germ cell tumor, non-metastatic invasive breast cancer, soft tissue sarcoma, osteosarcoma or Ewing's sarcoma at Centre Leon Berard (Lyon, France). The program consists on exhaustive identification of 22 complications at 1 month, 6 months, 24 months and 60 months after the end of first line treatment: social precariousness, return-to-work issues, cognitive problems, anxiety and depression disorders, chronic fatigue, physical deconditioning, overweight/obesity, chronic pain, dermatological disorders, gastrointestinal disorders, sexual disorders, hypogonadism, premature ovarian failure, osteoporosis, chronic kidney failure, heart failure, coronary heart disease, respiratory failure, hypothyroidism, lymphedema, modifiable risk factors associated with the occurrence of secondary cancers. Each identification will give rise to management, which consists of referring the patient to a healthcare professional belonging to the network of dedicated healthcare professionals at the regional level. The course of action to be followed will be defined using decision trees based on international, national or learned society recommendations. Referral outside Centre Leon Berard will be made to a specialist doctor, a health professional from the paramedical field or the patient's general practitioner who will confirm the diagnosis and initiate patient management and follow-up. These patients will also benefit from their usual follow-up in the context of their initial malignancy. Each study visit will include a search for clinical signs using questionnaires, an assay of 12 biological parameters, a urine test strip, 5 tests evaluating physical deconditioning and an electrocardiogram. The weight, height, waist circumference, blood pressure will also be measured. Primary outcome will be the incidence of the 22 complications, measured at 1 month, 6 months, 24 months and 60 months after the end of intensive chemotherapy treatment. Ethics and dissemination The study protocol was approved by the French ethics committee (Comité de protection des personnes Ile de France IV), the study database is currently being declared and registered to the Commission Nationale de l'Informatique et des Libertés (CNIL) and the study on ClinicalTrials.gov. The results will be disseminated to patients and in peer-reviewed journals and academic conferences. Strengths and limitations of this study This study is based on a previous feasibility study with 52 patients recruited in onco-hematology, which demonstrated the feasibility of the intervention and the existence of patient management needs.(1) The study design does not include a comparator arm, as the objective of the study is to provide a comprehensive picture of treatment-related complications, especially those that appear over the long term. Due to the lack of recent data concerning some complications, sample size was calculated empirically on the basis of the active queue of patients at the Centre Leon Berard. References Michallet M, Sobh M, Buono R, Poirey S, Pascu I, Nicolas-Virelizier E, et al. Personalised Follow-up Program after Acute Phase of Treatment in Oncology/Hematology Patients Towards Early Intervention, Better Care and Quality of Life Improvement: Results from Pasca Pilot Study. Blood. 13 nov 2019;134(Supplement_1):5817-5817. Disclosures Nicolini: Sun Pharma Ltd: Consultancy; Incyte: Research Funding, Speakers Bureau; Novartis: Research Funding, Speakers Bureau.
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Bernier, Gaston. "Mémoire à la Commission parlementaire de la Justice de l’Assemblée nationale du Québec." Documentation et bibliothèques 21, no. 2 (January 16, 2019): 73–76. http://dx.doi.org/10.7202/1055498ar.
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Le mémoire présenté par le comité mixte ASTED/CBPQ/ABQ-QLA à la Commission parlementaire de la Justice de l’Assemblée nationale dans le cadre de la discussion du projet de loi sur les droits et les libertés de la personne comprend deux recommandations principales : d’abord que le droit à l’information soit incorporé aux libertés fondamentales comme garantie de l’exercice des autres libertés, puis que la documentation gouvernementale (documents administratifs, rapports d’enquête, arrêtés en conseil) soit considérée comme publique.
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Dautieu, Thomas. "La Commission nationale de l’informatique et des libertés, régulateur des données de santé." Les Tribunes de la santé N° 58, no. 1 (2018): 47. http://dx.doi.org/10.3917/seve1.058.0047.
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Blanchot-Isola, C. "Zoom sur la Commission nationale de l’informatique et des libertés (CNIL) http://www.cnil.fr/." La Revue Sage-Femme 10, no. 6 (December 2011): 275–78. http://dx.doi.org/10.1016/j.sagf.2011.10.005.
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Coutu, Michel. "Les clauses dites « orphelins » et la notion de discrimination dans la Charte des droits et libertés de la personne." Articles 55, no. 2 (April 12, 2005): 308–31. http://dx.doi.org/10.7202/051310ar.
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Les clauses dites « orphelins » ont été introduites au Québec vers le milieu des années 80. Récemment, un débat très vif a eu cours au sujet de la validité de ces clauses. La question du caractère discriminatoire ou non des clauses « orphelins », par rapport à la Charte des droits et libertés de la personne, a occupé fréquemment le devant de la scène au Québec pour aboutir à l'adoption, par l'Assemblée nationale, du projet de loi n" 67 modifiant la Loi sur les normes du travail. Cet article présente d'abord le concept de discrimination et ses possibilités d'application au phénomène des clauses « orphelins », étudie la portée des exceptions au principe de discrimination dans l'emploi qui pourraient faire écran à d'éventuelles plaintes en ce domaine, pour examiner enfin la juridiction respective de la Commission des normes du travail et de la Commission des droits de la personne et des droits de la jeunesse.
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Shore, Jacques J. M. "An Evaluation of Canada's Dangerous Offender Legislation." Les Cahiers de droit 25, no. 2 (April 12, 2005): 411–26. http://dx.doi.org/10.7202/042598ar.
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L'auteur s'intéresse dans cet article à la partie XXI du Code criminel relative aux délinquants dangereux. L'évolution historique des dispositions législatives concernées est tracée à l'aide d'une comparaison avec la législation en vigueur en 1977. Les problèmes juridiques découlant de ces dispositions et les objectifs de la législation sont ensuite présentés ainsi que la procédure spécifique d'obtention d'une sentence de période indéterminée. L'auteur décrit les difficultés d'application de la loi et identifie certains résultats incongrus transparaissant de la jurisprudence récente. De plus, l'impact potentiel des articles 1, 9, 11 et 12 de la Charte canadienne des droits et libertés sur la partie XXI du Code criminel est évoqué. L'auteur critique les procédures de remise en liberté des délinquants dangereux et suggère que les tribunaux plutôt que la Commission nationale des libérations conditionnelles soient habilités à rescinder une sentence de période indéterminée. L'article conclut en recommandant que les dispositions existantes de la loi relatives aux délinquants dangereux soient abrogées et qu'un nouveau régime sentenciel, excluant l'option d'une sentence pour une période indéterminée, soit établi. L'auteur suggère également, advenant que la législation actuelle relative aux délinquants dangereux perdure, que soient réévaluées les règles de preuve et d'audition responsables de l'échec du système existant.
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Murall, Carmen Lía, Massilva Rahmoun, Christian Selinger, Monique Baldellou, Claire Bernat, Marine Bonneau, Vanina Boué, et al. "Natural history, dynamics, and ecology of human papillomaviruses in genital infections of young women: protocol of the PAPCLEAR cohort study." BMJ Open 9, no. 6 (June 2019): e025129. http://dx.doi.org/10.1136/bmjopen-2018-025129.
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IntroductionHuman papillomaviruses (HPVs) are responsible for one-third of all cancers caused by infections. Most HPV studies focus on chronic infections and cancers, and we know little about the early stages of the infection. Our main objective is to better understand the course and natural history of cervical HPV infections in healthy, unvaccinated and vaccinated, young women, by characterising the dynamics of various infection-related populations (virus, epithelial cells, vaginal microbiota and immune effectors). Another objective is to analyse HPV diversity within hosts, and in the study population, in relation to co-factors (lifestyle characteristics, vaccination status, vaginal microbiota, human genetics).Methods and analysisThe PAPCLEAR study is a single center longitudinal study following 150 women, aged 18–25 years, for up to 2 years. Visits occur every 2 or 4 months (depending on HPV status) during which several variables are measured, such as behaviours (via questionnaires), vaginal pH, HPV presence and viral load (via qPCR), local concentrations of cytokines (via MesoScale Discovery technology) and immune cells (via flow cytometry). Additional analyses are outsourced, such as titration of circulating anti-HPV antibodies, vaginal microbiota sequencing (16S and ITS1 loci) and human genotyping. To increase the statistical power of the epidemiological arm of the study, an additional 150 women are screened cross-sectionally. Finally, to maximise the resolution of the time series, participants are asked to perform weekly self-samples at home. Statistical analyses will involve classical tools in epidemiology, genomics and virus kinetics, and will be performed or coordinated by the Centre National de la Recherche Scientifique (CNRS) in Montpellier.Ethics and disseminationThis study has been approved by the Comité de Protection des Personnes Sud Méditerranée I (reference number 2016-A00712-49); by the Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le domaine de la Santé (reference number 16.504); by the Commission Nationale Informatique et Libertés (reference number MMS/ABD/AR1612278, decision number DR-2016–488) and by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (reference 20160072000007). Results will be published in preprint servers, peer-reviewed journals and disseminated through conferences.Trial registration numberNCT02946346; Pre-results.
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Fahey, Marion, Anthony Rudd, Yannick Béjot, Charles Wolfe, and Abdel Douiri. "Development and validation of clinical prediction models for mortality, functional outcome and cognitive impairment after stroke: a study protocol." BMJ Open 7, no. 8 (August 2017): e014607. http://dx.doi.org/10.1136/bmjopen-2016-014607.
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IntroductionStroke is a leading cause of adult disability and death worldwide. The neurological impairments associated with stroke prevent patients from performing basic daily activities and have enormous impact on families and caregivers. Practical and accurate tools to assist in predicting outcome after stroke at patient level can provide significant aid for patient management. Furthermore, prediction models of this kind can be useful for clinical research, health economics, policymaking and clinical decision support.Methods2869 patients with first-ever stroke from South London Stroke Register (SLSR) (1995–2004) will be included in the development cohort. We will use information captured after baseline to construct multilevel models and a Cox proportional hazard model to predict cognitive impairment, functional outcome and mortality up to 5 years after stroke. Repeated random subsampling validation (Monte Carlo cross-validation) will be evaluated in model development. Data from participants recruited to the stroke register (2005–2014) will be used for temporal validation of the models. Data from participants recruited to the Dijon Stroke Register (1985–2015) will be used for external validation. Discrimination, calibration and clinical utility of the models will be presented.EthicsPatients, or for patients who cannot consent their relatives, gave written informed consent to participate in stroke-related studies within the SLSR. The SLSR design was approved by the ethics committees of Guy’s and St Thomas’ NHS Foundation Trust, Kings College Hospital, Queens Square and Westminster Hospitals (London). The Dijon Stroke Registry was approved by the Comité National des Registres and the InVS and has authorisation of the Commission Nationale de l’Informatique et des Libertés.
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Georgiou, Dimitra, and Costas Lambrinoudakis. "Data Protection Impact Assessment (DPIA) for Cloud-Based Health Organizations." Future Internet 13, no. 3 (March 7, 2021): 66. http://dx.doi.org/10.3390/fi13030066.
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The General Data Protection Regulation (GDPR) harmonizes personal data protection laws across the European Union, affecting all sectors including the healthcare industry. For processing operations that pose a high risk for data subjects, a Data Protection Impact Assessment (DPIA) is mandatory from May 2018. Taking into account the criticality of the process and the importance of its results, for the protection of the patients’ health data, as well as the complexity involved and the lack of past experience in applying such methodologies in healthcare environments, this paper presents the main steps of a DPIA study and provides guidelines on how to carry them out effectively. To this respect, the Privacy Impact Assessment, Commission Nationale de l’Informatique et des Libertés (PIA-CNIL) methodology has been employed, which is also compliant with the privacy impact assessment tasks described in ISO/IEC 29134:2017. The work presented in this paper focuses on the first two steps of the DPIA methodology and more specifically on the identification of the Purposes of Processing and of the data categories involved in each of them, as well as on the evaluation of the organization’s GDPR compliance level and of the gaps (Gap Analysis) that must be filled-in. The main contribution of this work is the identification of the main organizational and legal requirements that must be fulfilled by the health care organization. This research sets the legal grounds for data processing, according to the GDPR and is highly relevant to any processing of personal data, as it helps to structure the process, as well as be aware of data protection issues and the relevant legislation.
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Zolynski, Célia. "OS BIG DATA E OS DADOS PESSOAIS ENTRE OS PRINCÍPIOS DA PROTEÇÃO E DA INOVAÇÃO." Law, State and Telecommunications Review 12, no. 1 (March 16, 2020): 225–45. http://dx.doi.org/10.26512/lstr.v12i1.30007.
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Objective ”“ The article contrasts the problem of Big Data with the possibilities and limits of personal data protection. It is an original contribution to the academic discussion about the regulation of the Internet and the management of algorithms, focusing on Big Data.
Methodology/approach/design ”“ The article provides bibliographic research on the opposition between Big Data and personal data protection, focusing on European Union law and French law. From the research is possible to identify regulatory alternatives do Big Data, whether legal-administrative nature or technological nature.
Findings ”“ The article enlightens that, in addition to the traditional regulatory options, based on the law, there are technological options for regulating Big Data and algorithms. The article goes through an analysis of administrative performance, such as France’s CNIL (Commission nationale informatique et libertés, CNIL), to show that it has limits. Thus, the article concludes that there is a need to build a new type of regulation, one that is open to the inputs of regulated parties and civil society, in the form of new co-regulatory arrangements.
Practical implications ”“ The article has an obvious application since the production of legal solutions for Internet regulation requires combining them with technological solutions. Brazil and several Latin American countries are experiencing this agenda, as they are building institutions and solutions to solve the dilemma of personal data protection.
Originality/value ”“ The article clarifies several parts of the General Data Protection Regulation (EU Regulation 2016/679) and its applicability to Big Data. These new types of data processing impose several legal and regulatory challenges, whose solutions cannot be trivial and will rely on new theories and practices.
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Binda, Francesca, Sébastien Fougnot, Patrice De Monchy, Anne Fagot-Campagna, Céline Pulcini, and Nathalie Thilly. "Impact of selective reporting of antibiotic susceptibility test results in urinary tract infections in the outpatient setting: a protocol for a pragmatic, prospective quasi-experimental trial." BMJ Open 8, no. 11 (November 2018): e025810. http://dx.doi.org/10.1136/bmjopen-2018-025810.
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IntroductionAntibiotic resistance is a serious and increasing worldwide threat to global public health. One of antibiotic stewardship programmes’ objectives are to reduce inappropriate broad-spectrum antibiotics’ prescription. Selective reporting of antibiotic susceptibility test (AST) results, which consists of reporting to prescribers only few (n=5-6) antibiotics, preferring first-line and narrow-spectrum agents, is one possible strategy advised in recommendations. However, selective reporting of AST has never been evaluated using an experimental design.Methods and analysisThis study is a pragmatic, prospective, multicentre, controlled (selective reporting vs usual complete reporting of AST), before-after (year 2019 vs 2017) study. Selective reporting of AST is scheduled to be implemented from September 2018 in the ATOUTBIO group of 21 laboratories for all Escherichia coli identified in urine cultures in adult outpatients, and to be compared with the usual complete AST performed in the EVOLAB group of 20 laboratories. The main objective is to assess the impact of selective reporting of AST for E. coli-positive urine cultures in the outpatient setting on the prescription of broad-spectrum antibiotics frequently used for urinary tract infections (amoxicillin-clavulanate, third-generation cephalosporins and fluoroquinolones). The primary end point is the after (2019)–before (2017) difference in prescription rates for the previously mentioned antibiotics/classes that will be compared between the two laboratory groups, using linear regression models. Secondary objectives are to evaluate the feasibility of selective reporting of AST implementation by French laboratories and their acceptability by organising focus groups and individual semi-structured interviews with general practitioners and laboratory professionals.Ethics and disseminationThis protocol was approved by French national ethics committees (Comité d’expertise pour les recherches, les études et les évaluations dans le domaine de la santé (TPS 29064) and Commission Nationale de l’Informatique et des Libertés (Décision DR-2018–141)). Findings of this study will be widely disseminated through conference presentations, reports, factsheets and academic publications and generalisation will be further discussed.Trial registration numberNTC03612297.
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Zalnieriute, Monika. "Google LLC v. Commission Nationale de l’informatique et des Libertés (CNIL)." SSRN Electronic Journal, 2020. http://dx.doi.org/10.2139/ssrn.3516337.
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Robitaille, Amélie. "Commission nationale de l’informatique et des libertés (cnil): rapport d’activité 2010." Revue des droits de l’homme, November 23, 2011. http://dx.doi.org/10.4000/revdh.10836.
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"Diversity Measurement and Protection of Confidential Data: The Ten Recommendations of the CNIL (Commission nationale de l'informatique et des libertés)." French Politics, Culture & Society 26, no. 1 (January 1, 2008). http://dx.doi.org/10.3167/fpcs.2008.260105.
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Monier, Pierre Antoine, Jan Chrusciel, Fiona Ecarnot, Eduardo Bruera, Stephane Sanchez, and Cecile Barbaret. "Duration of palliative care involvement and cancer care aggressiveness near the end of life." BMJ Supportive & Palliative Care, December 21, 2020, bmjspcare—2020–002641. http://dx.doi.org/10.1136/bmjspcare-2020-002641.
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ObjectivesPrevious studies have found an association between aggressive cancer care and lower quality end of life. Despite international recommendations, late or very late referral to palliative care seems frequent. This study aimed to evaluate the association between the duration of involvement of a palliative care team (PCT), and aggressive cancer care, and to identify factors associated with aggressive cancer care.MethodsWe performed an observational retrospective study in a single academic teaching hospital. In total, 561 inpatients with solid tumours or haematological malignancies were included. Patients followed by a PCT for at least 1 month before death were classified in the palliative care group. Aggressive cancer care was defined as: hospitalisations and/or a new line of chemotherapy within the last month of life, location of death, the use of chemotherapy in the last 2 weeks and hospice admissions within the last 3 days of life.ResultsAmong the 561 patients, 241 (43%) were referred to the PCT; 89 (16%) were followed by the PCT for a month or more before death. In the last 2 weeks of life, 124 (22%) patients received chemotherapy, 110 (20%) died in an acute care unit. At least one criterion of aggressive cancer care was found in 395 patients overall (71%). Aggressive cancer care was significantly less frequent when the PCT referral occurred >1 month before death (p<0.0001).ConclusionMore studies are needed to understand reasons for late referrals despite international recommendations encouraging integrative palliative care.Ethics approvalThe study was approved by the Grenoble Teaching Hospital ethics committee, and by the CNIL (French national commission for data privacy; Commission Nationale de l’Informatique et des Libertés) under the number 1987785 v 0. Due to ethical and legal restrictions, data are only available on request.
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Muller, Marie, François Lefebvre, Marie-Line Harlay, Ludovic Glady, Guillaume Becker, Charlotte Muller, Ouafaa Aberkane, et al. "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 22, no. 1 (February 11, 2021). http://dx.doi.org/10.1186/s13063-021-05095-x.
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Abstract Objectives The main objective of this study is to evaluate the effect of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome due or not to Covid-19 pneumonia. Trial design This is a prospective monocentric, randomized, quadruple-blinded and placebo-controlled superiority trial. This phase 3 clinical study is based on two parallel groups received either intravenous lidocaine 2% or intravenous NaCl 0.9%. Participants This study has been conducted at the University Hospitals of Strasbourg (medical and surgical Intensive Care Units in Hautepierre Hospital) since the 4th November 2020. The participants are 18 years-old and older, hospitalized in ICU for a moderate to severe ARDS according to the Berlin definition; they have to be intubated and sedated for mechanical protective ventilation. All participants are affiliated to the French Social security system and a dosage of beta HCG has to be negative for women of child bearing age . For the Covid-19 subgroup, the SARS-CoV2 infection is proved by RT-PCR <7 days before admission and/or another approved diagnostic technique and/or typical CT appearance pneumonia. The data are prospectively collected in e-Case Report Forms and extracted from clinical files. Intervention and comparator The participants are randomised in two parallel groups with a 1:1 ratio. In the experimental group, patients receive intravenous lidocaine 2% (20mg/mL) (from FRESENIUS KABI France); the infusion protocol provide a bolus of 1 mg/kg (ideal weight), followed by 3 mg/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 0.6 mg/kg/h for 14 days at most or 24 hours after extubation or ventilator-weaning. The patients in the control group receive intravenous NaCl 0.9% (9 mg/mL) (from Aguettant, France) as placebo comparator; the infusion protocol provide 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, 0.036 mL/kg/h for the next 22 hours, and the 0.03 mL/kg/h for up to 14 days or 24 hours after extubation or ventilator-weaning. Lidocaine level is assessed at H4, D2, D7 and D14 to prevent local anesthetics systemic toxicity. Clinical data and biological samples are collected to assess disease progression. Main outcomes The primary outcome is the evolution of alveolar-capillary gas exchange measured by the PaO2/FiO2 ratio after two days of treatment. The secondary endpoints of the study include the following: Evolution of PaO2/FiO2 ratio at admission and after 21 days of treatment Number of ventilator-free days Anti-inflammatory effects by dosing inflammatory markers at different timepoints (ferritin, bicarbonate, CRP, PCT, LDH, IL-6, Troponin HS, triglycerides, complete blood count, lymphocytes) Anti-thrombotic effects by dosing platelets, aPTT, fibrinogen, D-dimers, viscoelastic testing and identification of all thromboembolic events up to 4 weeks. Plasmatic concentration of lidocaine and albumin Incidence of adverse events like cardiac rhythm disorders, need of vasopressors, any modification of the QRS, QTc or PR intervals every day Ileus recovery time Consumption of hypnotics, opioids, neuromuscular blockers. Lengths of stay in the ICU, incidence of reintubation and complications due to intensive care unit care (mortality until 90 days, pneumothorax, bacterial pneumopathy, bronchospasm, cardiogenic shock, acute renal failure, need of renal dialysis, delirium, atrial fibrillation, stroke (CAM-ICU score), tetraplegia (MCR score)). Incidence of cough and sore throat at extubation or ventilator-weaning and within 24 hours. All these outcomes will be evaluated according to positivity to Sars-Cov-2. Randomisation The participants who meet the inclusion criteria and have signed written informed consent will be randomly allocated using a computer-generated random number to either intervention group or control group. The distribution ratio of the two groups will be 1:1, with a stratification according to positivity to Sars-Cov-2. Blinding (masking) All participants, care providers, investigator and outcomes assessor are blinded. Numbers to be randomised (sample size) We planned to randomize fifty participants in each group, 100 participants total. Trial Status The amended protocol version 2.1 was approved by the Ethics Committee “Comité de Protection des Personnes Sud-Méditerranée II on January 8, 2021 and by the Commission Nationale de l’Informatique et des Libertés (CNIL) on November 10, 2020. The study is currently recruiting participants; the recruitment started in November 2020 and the planned recruitment period is three years. Trial registration The trial was registered on clinicaltrials.gov on October 30, 2020 and identified by number NCT04609865. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.