NRT in ICU Pilot

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Pathak V, et al. "Outcome of Nicotine Replacement Therapy in Patients Admitted to ICU: A Randomized Controlled Double-Blind Prospective Pilot Study". Respiratory Care. 2013. 58(10):1625-1629.
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Clinical Question

Among patients admitted to the intensive care unit (ICU) with a history of smoking at least one pack-per-day, does the use of nicotine replacement (NRT) therapy decrease the length of ICU stay and increase ventilator free days in intubated patients compared to a placebo patch.

Bottom Line

The use of NRT may help to decrease length of ICU stay, duration of ventilation, and use of analgesia and sedation, but larger trials are necessary to determine if the benefit outweighs the risk of adverse events and toxicity.

Major Points

The use of nicotine replacement therapy (NRT) among smokers admitted to the ICU is controversial. A systematic review in 2014,[1] which included a majority of retrospective cohort studies, suggests that the risk of NRT may not outweigh the benefits. The authors go on to suggest an RCT would be required to answer the question, the very place this trial fits. This small pilot study randomized 40 ICU patients to NRT or placebo. It found a trend towards improved outcomes in terms of time in ICU, length of mechanical ventilation, and use of sedation and analgesia. This trial did not reach statistical significance nor did it assess/report adverse events. Other retrospective cohort trials such as NRT in ICU Cohort have been published showing potential harm in these patients so a large RCT is necessary to answer the clinical question. This larger RCT completed in August 2016 and is awaiting publication [2] which may better address this question.

Guidelines

To date, no guidelines include findings of this trial

Design

  • Single center, placebo-controlled, double-blind, randomized, pilot study
  • N=40
    • NRT (n=20)
    • Placebo (n=20)
  • Setting: 20-bed mixed medical/surgical ICU
  • Mean follow-up: Through ICU stay only
  • Analysis: ITT
  • Primary Outcome:
    • ICU Length of Stay
    • Duration of Mechanical Ventilation
  • Secondary Outcomes:
    • Duration of sedatives
    • Duration of analgesics
    • Duration of vasopressor support

Population

Inclusion Criteria

  • admitted to intensive care unit
  • ± ventilator
  • Informed consent from subject or delegate
  • Smoked 1 pack of cigarettes per day for more than 1 year
  • No contradiction to nicotine use
  • >18 years old

Exclusion Criteria

  • Myocardial infarction in last 2 weeks
  • Unstable angina
  • Uncontrolled or serious arrhythmia
  • Pregnancy
  • Severe allergic reaction to nicotine or patch
  • Peptic ulcer disease
  • Hyperthyroidism

Baseline Characteristics

‘'Presented as NRT vs. PBO’'

  • Age (mean): 57.4 vs. 52.5 (NSS)
  • Male: 27
  • APACHE II score (mean): 14.3 vs. 13.8 (NSS)
  • Packs per day (mean): 1.2 vs. 1.0 (NSS)
  • Duration of smoking (mean, years): 24.4 vs. 23.3 (NSS)
  • Intubated/Ventilated(No.): 20 vs 20
  • Ethnicity (No.)
    • Hispanic: 10 vs. 10
    • African American: 5 vs. 5
    • White: 5 vs. 5

Interventions

  • 21mg nicotine patch applied daily until death, transfer, discharge, or 10 weeks (then tapered if remained in ICU)
  • Placebo Patch

Outcomes

Comparisons are NRT vs. PBO ± SD (P-value)

Primary Outcomes

ICU Length of Stay, days
4.5 vs. 7 (NSS)
Days on Ventilator
1.9 ± 3.7 vs. 3.5 ± 5.3 (NSS)

Secondary Outcomes

Days receiving analgesia
1.1 ± 2.6 vs. 2.1 ± 3.8 (NSS)
Days receiving sedation
1.4 ± 2.5 vs. 2.7 ± 4.6 (NSS)
Days receiving vasopressor support
0.7 ± 1.6 vs. 2.1 ± 3.8 (NSS)

Adverse Events

Not assessed by this trial

Criticisms

  • Likely underpowered, though this was a pilot study
  • Trial did not assess for adverse events
  • Unable to assess randomization
  • Did not report indications of ICU admission or indication for intubation, unclear if this is a hetero or homogenous population, unable to assess this trials external validity
  • No use of an objective measure such as the CAM-ICU[3] to assess and report of delirium and how they compared
  • Unclear what the average/baseline outcomes for the average patient in their ICU to see how these patients compare.

Funding

"Investigator initiated and funded" according to the ISRCTN registration[4]

Further Reading

  1. Wilby KJ & Harder CK Nicotine replacement therapy in the intensive care unit: a systematic review. J Intensive Care Med 2014. 29:22-30.
  2. Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell) listing on Clinicaltrials.gov
  3. Ely EW et al. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit. Care Med. 2001. 29:1370-9.
  4. ISRCTN listing for this study