Phase 4
N=47
Nicotine Replacement Therapy in the Intensive Care Unit
Delirium · Psychomotor Agitation · Substance Withdrawal Syndrome · Nicotine Replacement Therapy
Bottom Line
View on ClinicalTrials.gov: NCT01362959 ↗Enrolled (actual)
47
Serious AEs
31.9%
Results posted
Oct 2018
Primary outcome: Primary: 30-day Mortality — 9.5; 7.7 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Transdermal nicotine patch (Drug); Cutaneous patch, containing no active substances (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gelderse Vallei Hospital
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 30-day Mortality |
9.5; 7.7 | — |
| PRIMARY Patient Location Day 30 |
1; 11 | — |
| SECONDARY 90-day Mortality |
14.3; 19.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01362959). 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.