Nicotine Replacement Therapy in the Intensive Care Unit
Condition: Delirium; Psychomotor Agitation; Substance Withdrawal Syndrome; Nicotine Replacement Therapy
MeSH terms: Delirium; Psychomotor Agitation; Substance Withdrawal Syndrome
Intervention: Transdermal nicotine patch; Cutaneous patch, containing no active substances
Intervention description: The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applicated daily.; During the study period of thirty (30) days, the control product will be applicated daily.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Delirium; Psychomotor Agitation; Substance Withdrawal Syndrome; Nicotine replacement therapy

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.
    

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