Evidence map›Paper›PMID 35676335›Full record

Trial reportIntensive care medicine2022

Nicotine patches in patients on mechanical ventilation for severe COVID-19: a randomized, double-blind, placebo-controlled, multicentre trial.

Guylaine Labro, Florence Tubach, Lisa Belin, Jean-Louis Dubost, David Osman, Grégoire Muller, Jean-Pierre Quenot, Daniel Da Silva, Jonathan Zarka, Matthieu Turpin and 18 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Intensive care medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Guylaine LabroService de Médecine Intensive-Réanimation Groupement Hospitalier Régional Mulhouse Et Sud Alsace, Hôpital Emile Muller, 68100, Mulhouse, France.
Florence Tubach *Département de Santé Publique, Unité de Recherche Clinique PSL-CFX, INSERM, Institut Pierre Louis d'Epidémiologie Et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Sorbonne Université, CIC-1901, 75013, Paris, France.
Lisa BelinDépartement de Santé Publique, Unité de Recherche Clinique PSL-CFX, INSERM, Institut Pierre Louis d'Epidémiologie Et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Sorbonne Université, CIC-1901, 75013, Paris, France.
Jean-Louis DubostCentre Hospitalier René Dubos, 6, avenue de l'Ile de, 95303, Cergy-Pontoise, France.
David OsmanCHU Bicêtre, 78 Rue du Général Leclerc, 94270, Le Kremlin-Bicêtre, France.
Grégoire MullerService de Médecine Intensive Réanimation, Centre Hospitalier Régional d'Orléans, Orléans, France.
Jean-Pierre QuenotDepartment of Intensive Care, Burgundy University Hospital, Dijon, France.
Daniel Da SilvaService de Médecine Intensive Réanimation du Centre, Hospitalier de Saint-Denis, Saint-Denis, France.
Jonathan ZarkaService de Réanimation Polyvalente, Grand Hôpital de L'Est Francilien, site de Marne-La-Vallée, Jossigny, France.
Matthieu TurpinAssistance Publique - Hôpitaux de Paris, Service de Médecine Intensive RéanimationHôpital Tenon, Sorbonne Université, Paris, France.
Julien MayauxGroupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Médecine Intensive Et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale Et Clinique, Sorbonne Université, Paris, France.
Christian LamerService de RéanimationInstitut Mutualiste Montsouris, 42 Bd Jourdan, 75014, Paris, France.
Denis DoyenMédecine Intensive RéanimationHôpital L'Archet 1, Centre Hospitalier Universitaire de Nice, Nice, France.
Guillaume ChevrelService de Réanimation; Centre Hospitalier Sud Francilien (CHSF), 40 Avenue Serge Dassault, Corbeil-Essonne, France.
Gaétan PlantefeveService de Médecine Intensive-Réanimation, Centre Hospitalier Victor Dupouy, 95107, Argenteuil, France.
Sophie DemeretMédecine Intensive Réanimation À Orientation Neurologique - Site Pitié Salpêtrière - Sorbonne Université, Assistance Publique - Hôpitaux de Paris, Paris, France.
Gaël PitonService de Réanimation Médicale, CHRU de Besançon, Boulevard Fleming, Besançon, France.
Cyril ManzonService de Réanimation, Médipole Lyon Villeurbanne. Service de Réanimation, 158 rue Léon Blum, 69100, Villeurbanne, France.
Evelina OchinService de Médecine Intensive-Réanimation Hôpital Simone Veil, Eaubonne, France.
Raphael GaillardDepartment of Psychiatry, Service Hospitalo-Universitaire, GHU Paris Psychiatrie & Neurosciences, 75014, Paris, France.
Bertrand DautzenbergSorbonne Université APHP (La Pitié-Salpêtrière), 75013, Paris, France.
Mathieu BaldaciniService de Médecine Intensive-Réanimation Groupement Hospitalier Régional Mulhouse Et Sud Alsace, Hôpital Emile Muller, 68100, Mulhouse, France.
Said LebbahDépartement de Santé Publique, Unité de Recherche Clinique PSL-CFX, INSERM, Institut Pierre Louis d'Epidémiologie Et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Sorbonne Université, CIC-1901, 75013, Paris, France.
Makoto MiyaraService de Médecine Interne 2, Institut E3M, CRMR Lupus. SAPL Et Autres Maladies Auto-Immunes, Hôpital Pitié Salpêtrière Et Université Paris 6, Paris, France.
Marc Pineton de ChambrunService de Médecine Intensive-Réanimation, Institut de Cardiologie, APHP Hôpital Pitié-Salpêtrière, 75013, Paris, France.
Zahir Amoura *Department of Psychiatry, Service Hospitalo-Universitaire, GHU Paris Psychiatrie & Neurosciences, 75014, Paris, France.
Alain Combes *Service de Médecine Intensive-Réanimation, Institut de Cardiologie, APHP Hôpital Pitié-Salpêtrière, 75013, Paris, France. alain.combes@aphp.fr.ORCID http://orcid.org/0000-0002-6030-3957
NICOVID-REA Trial Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeEpidemiologic studies have documented lower rates of active smokers compared to former or non-smokers in symptomatic patients affected by coronavirus disease 2019 (COVID-19). We assessed the efficacy and safety of nicotine administered by a transdermal patch in critically ill patients with COVID-19 pneumonia.

methodsIn this multicentre, double-blind, placebo-controlled trial conducted in 18 intensive care units in France, we randomly assigned adult patients (non-smokers, non-vapers or who had quit smoking/vaping for at least 12 months) with proven COVID-19 pneumonia receiving invasive mechanical ventilation for up to 72 h to receive transdermal patches containing either nicotine at a daily dose of 14 mg or placebo until 48 h following successful weaning from mechanical ventilation or for a maximum of 30 days, followed by 3-week dose tapering by 3.5 mg per week. Randomization was stratified by centre, non- or former smoker status and Sequential Organ Function Assessment score (< or ≥ 7). The primary outcome was day-28 mortality. Main prespecified secondary outcomes included 60-day mortality, time to successful extubation, days alive and free from mechanical ventilation, renal replacement therapy, vasopressor support or organ failure at day 28.

resultsBetween November 6th 2020, and April 2nd 2021, 220 patients were randomized from 18 active recruiting centers. After excluding 2 patients who withdrew consent, 218 patients (152 [70%] men) were included in the analysis: 106 patients to the nicotine group and 112 to the placebo group. Day-28 mortality did not differ between the two groups (30 [28%] of 106 patients in the nicotine group vs 31 [28%] of 112 patients in the placebo group; odds ratio 1.03 [95% confidence interval, CI 0.57-1.87]; p = 0.46). The median number of day-28 ventilator-free days was 0 (IQR 0-14) in the nicotine group and 0 (0-13) in the placebo group (with a difference estimate between the medians of 0 [95% CI -3-7]). Adverse events likely related to nicotine were rare (3%) and similar between the two groups.

conclusionIn patients having developed severe COVID-19 pneumonia requiring invasive mechanical ventilation, transdermal nicotine did not significantly reduce day-28 mortality. There is no indication to use nicotine in this situation.

Indexed as

COVID-19AdultDouble-Blind MethodFemaleHumansIntensive Care UnitsMaleNicotineRespiration, ArtificialSARS-CoV-2Treatment OutcomeNicotineAcute respiratory failureArtificialCOVID-19Intensive care unitsNicotineNicotinic receptorRandomized trialVentilation

Identifiers

PMID35676335
PMCPMC9177407

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.