Nicotine Replacement Therapy in the Intensive Care Unit : A Randomized Controlled Pilot Study

Schuppers, A. (Anne) (2017) Nicotine Replacement Therapy in the Intensive Care Unit : A Randomized Controlled Pilot Study. thesis, Medicine.

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Abstract

Introduction: Delirium and agitation are common in mechanically ventilated patients admitted to the intensive care unit (ICU). Retrospective data have shown that smoking, or the acute abstinence of smoking, is an additional risk factor for agitation. A safe and effective method to treat nicotine withdrawal symptoms in outpatient and hospitalized smoking adults is transdermal nicotine replacement therapy (NRT). Previous studies on the use of transdermal NRT in critically ill smokers admitted to the ICU have produced conflicting results. The aim of this study was to assess the safety and efficacy of transdermal NRT in mechanically ventilated smokers admitted to the ICU. Methods: In this two-centre, randomized, controlled pilot study, mechanically ventilated smokers admitted to the ICU were included. Subjects received either a nicotine patch (14 or 21 mg/day) or a placebo patch daily until ICU discharge or for a maximum of 30 days. The primary outcome was 30-day mortality. Secondary outcomes included 90-day mortality, length of stay, duration of ventilation, delirium, RASS score, SOFA score, hours of physical restraint, incidence of new nosocomial infections, number of self-removed devices and number of (serious) adverse events. We performed a post hoc analysis and defined the outcome parameter as time spent in a favourable condition (alive without sedation and delirium in the ICU) during the first 30 days. Results: Due to recruitment failure the study was stopped after the inclusion of 47 patients. The two groups were comparable with respect to baseline characteristics. No differences were found in 30-day mortality and 90-day mortality between NRT and the control group (2/21 vs. 2/26; p=0.843 and 3/21 vs. 5/26; p=0.665). During the first 10 days the NRT group had spent more time in a ‘favourable’ condition (160 hours (96-216) vs. 88 hours (20-210) (p=0.043)) and during the first 20 days (400 hours (316-448) vs. 304 hours (110-432) (p=0.033)).There was no difference in the number of adverse and serious adverse events between NRT and control patients (102 vs. 177 (p=0.096) and 5 vs. 11 (p=0.251)). Conclusion: The results of this pilot study showed that with some modifications of the trial design, a randomized controlled study to assess the safety and efficacy of transdermal NRT in mechanically ventilated smokers admitted to the ICU is feasible. Transdermal NRT in mechanically ventilated smokers had no effect on 30- and 90-day mortality, although our study was underpowered to establish such differences. Furthermore, the number of (serious) adverse events between the two groups were comparable. Finally, patients with NRT spent more time in a ‘favourable’ condition during the first 20 days of admission to the ICU. We suggest that future trials should focus on a possible effect of NRT on predefined delirium and agitation endpoints, particularly in the second and third week of ICU stay.

Item Type:	Thesis (Thesis)
Supervisor name:	Faculty and daily supervisor: : and H. van den Oever, Deventer and Department of Intensive care
Supervisor name:	Second supervisor: and Jong, B. de MD and Gelderse Vallei Hospital Ede and Department of Intensive care Department of Intensive care and Currently working at Radboudumcg Nijmegen
Faculty:	Medical Sciences
Date Deposited:	25 Jun 2020 10:42
Last Modified:	25 Jun 2020 10:42
URI:	https://umcg.studenttheses.ub.rug.nl/id/eprint/397

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