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The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study

BACKGROUND: Studies evaluating nicotine replacement therapy (NRT) to prevent nicotine withdrawal symptoms in ICU patients have yielded conflicting results. We performed a randomised controlled double-blind pilot study to assess the safety and efficacy of NRT in critically ill patients. Mechanically...

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Autores principales: de Jong, Ben, Schuppers, Anne Sophie, Kruisdijk-Gerritsen, Arriette, Arbouw, Maurits Erwin Leo, van den Oever, Hubertus Laurentius Antonius, van Zanten, Arthur R. H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5991106/
https://www.ncbi.nlm.nih.gov/pubmed/29881956
http://dx.doi.org/10.1186/s13613-018-0399-1
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author de Jong, Ben
Schuppers, Anne Sophie
Kruisdijk-Gerritsen, Arriette
Arbouw, Maurits Erwin Leo
van den Oever, Hubertus Laurentius Antonius
van Zanten, Arthur R. H.
author_facet de Jong, Ben
Schuppers, Anne Sophie
Kruisdijk-Gerritsen, Arriette
Arbouw, Maurits Erwin Leo
van den Oever, Hubertus Laurentius Antonius
van Zanten, Arthur R. H.
author_sort de Jong, Ben
collection PubMed
description BACKGROUND: Studies evaluating nicotine replacement therapy (NRT) to prevent nicotine withdrawal symptoms in ICU patients have yielded conflicting results. We performed a randomised controlled double-blind pilot study to assess the safety and efficacy of NRT in critically ill patients. Mechanically ventilated patients admitted to two medical–surgical intensive care units and smoking more than 10 cigarettes per day before ICU admission were enrolled in this study. Participants were randomised to transdermal NRT (14 or 21 mg per day) or placebo until ICU discharge or day 30. Smoking status was confirmed by the biomarkers serum cotinine and urinary NNAL. The primary endpoint was 30-day mortality. Among secondary endpoints and post hoc endpoints, 90-day mortality, safety, time spent without delirium, sedation and coma, and patient destination at day 30 were addressed. RESULTS: We enrolled 47 patients. No differences were found between NRT and control group patients concerning 30-day mortality (9.5 vs. 7.7%, p = 0.84) and 90-day mortality (14.3 vs. 19.2%, p = 0.67). The number of serious adverse events was comparable between groups (NRT: 4, control: 11, p = 0.13). At day 20, average time alive without delirium, sedation and coma was 16.6 days among NRT patients versus 12.6 days among control patients (p = 0.03). At day 30, more NRT group patients were discharged from the ICU or hospital compared with controls (p = 0.03). CONCLUSIONS: NRT did not affect mortality or the number of (serious) adverse events compared with placebo. Time alive without delirium, sedation and coma at day 20 in NRT patients was longer than in control patients. An adequately powered randomised controlled trial to further study safety and efficacy of NRT in ICU patients seems feasible and is warranted. Trial registration ClinicalTrials.gov, number NCT01362959, registered 1 June 2011 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13613-018-0399-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-59911062018-06-21 The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study de Jong, Ben Schuppers, Anne Sophie Kruisdijk-Gerritsen, Arriette Arbouw, Maurits Erwin Leo van den Oever, Hubertus Laurentius Antonius van Zanten, Arthur R. H. Ann Intensive Care Research BACKGROUND: Studies evaluating nicotine replacement therapy (NRT) to prevent nicotine withdrawal symptoms in ICU patients have yielded conflicting results. We performed a randomised controlled double-blind pilot study to assess the safety and efficacy of NRT in critically ill patients. Mechanically ventilated patients admitted to two medical–surgical intensive care units and smoking more than 10 cigarettes per day before ICU admission were enrolled in this study. Participants were randomised to transdermal NRT (14 or 21 mg per day) or placebo until ICU discharge or day 30. Smoking status was confirmed by the biomarkers serum cotinine and urinary NNAL. The primary endpoint was 30-day mortality. Among secondary endpoints and post hoc endpoints, 90-day mortality, safety, time spent without delirium, sedation and coma, and patient destination at day 30 were addressed. RESULTS: We enrolled 47 patients. No differences were found between NRT and control group patients concerning 30-day mortality (9.5 vs. 7.7%, p = 0.84) and 90-day mortality (14.3 vs. 19.2%, p = 0.67). The number of serious adverse events was comparable between groups (NRT: 4, control: 11, p = 0.13). At day 20, average time alive without delirium, sedation and coma was 16.6 days among NRT patients versus 12.6 days among control patients (p = 0.03). At day 30, more NRT group patients were discharged from the ICU or hospital compared with controls (p = 0.03). CONCLUSIONS: NRT did not affect mortality or the number of (serious) adverse events compared with placebo. Time alive without delirium, sedation and coma at day 20 in NRT patients was longer than in control patients. An adequately powered randomised controlled trial to further study safety and efficacy of NRT in ICU patients seems feasible and is warranted. Trial registration ClinicalTrials.gov, number NCT01362959, registered 1 June 2011 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13613-018-0399-1) contains supplementary material, which is available to authorized users. Springer International Publishing 2018-06-07 /pmc/articles/PMC5991106/ /pubmed/29881956 http://dx.doi.org/10.1186/s13613-018-0399-1 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Research
de Jong, Ben
Schuppers, Anne Sophie
Kruisdijk-Gerritsen, Arriette
Arbouw, Maurits Erwin Leo
van den Oever, Hubertus Laurentius Antonius
van Zanten, Arthur R. H.
The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
title The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
title_full The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
title_fullStr The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
title_full_unstemmed The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
title_short The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
title_sort safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5991106/
https://www.ncbi.nlm.nih.gov/pubmed/29881956
http://dx.doi.org/10.1186/s13613-018-0399-1
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