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Phase 4 Completed N=47 Randomized Quadruple-blind Treatment

Nicotine Replacement Therapy in the Intensive Care Unit

Delirium · Psychomotor Agitation · Substance Withdrawal Syndrome · Nicotine Replacement Therapy
Source: ClinicalTrials.gov NCT01362959 ↗
Enrolled (actual)
47
Serious AEs
31.9%
Results posted
Oct 2018
Primary outcomePrimary: 30-day Mortality — 9.5; 7.7 percentage of patients
◆ Published Evidence
Emerging
17citations · ~2 / year
The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study.
Annals of intensive care · 2018 · Open access · Likely link

Summary

The purpose of this study is to determine whether transdermal nicotine replacement therapy is safe and effective for treating nicotine withdrawal symptoms in the critically ill smoking patient.

Linked Publications

  • The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study.
    Annals of intensive care · 2018 · 17 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
30-day Mortality
9.5; 7.7
PRIMARY
Patient Location Day 30
1; 11
SECONDARY
90-day Mortality
14.3; 19.2

Eligibility Criteria

Inclusion Criteria: Any patient admitted to the intensive care unit must meet all of the following criteria to be eligible for the study:

  • Critically ill active smoking patient
  • Being mechanically ventilated
  • Start of study product application within 48 hours after ICU admission
  • Expected to be mechanically ventilated for more than 48 hours after start of application of the study product

Exclusion Criteria: Any patient admitted to the intensive care unit meeting one or more of the following criteria is not eligible for the study:

  • Patient younger than 18 years
  • Patient or next of kin denying research authorization
  • Pregnancy
  • Breastfeeding women
  • History of chronic dementia or psychosis
  • (Acute) neurologic disease on admission, possibly confounding study objectives (TBI, stroke, ICH/SAH, seizures, meningitis, encephalitis, intracranial tumor)
  • Patient receiving any form of NRT within two weeks before admission
  • Patient not understanding Dutch
  • Patient with acute myocardial infarction
  • Patient with severe cardiac arrhythmia
  • Patient with unstable or deteriorating angina pectoris
  • Patient with generalized acute or chronic skin diseases interfering with NRT absorption
  • Patient with severe hearing deficiency
  • Moribund patient
  • Patient with known hypersensibility to nicotine or components of the transdermal therapeutic system
  • Patient with known hypersensibility to patches
  • Patient participating in an other study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01362959) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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