Nicotine Replacement Therapy in the Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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Cigarette smoking remains the leading cause of preventable disease and premature death worldwide. There are about 1.2 billion smokers in the world, half of whom will die from diseases caused by smoking. Smoking causes 5 million deaths per year, and if present trends continue, 10 million smokers per year are projected to die by 2025. Furthermore, abstinence from the highly addictive tobacco products can lead to withdrawal symptoms. Although these symptoms are non-life threatening in healthy and hospitalized adults they are not well described in the mechanically ventilated active smoking patient. Retrospective studies found a higher, lower or equal mortality in critically ill patients receiving nicotine replacement therapy compared to patients receiving no nicotine replacement. Because of these conflicting results and the absence of a randomized controlled trial studying the efficacy and safety of transdermal nicotine replacement therapy in the critically ill smoking patient a clinical study will be conducted.

Official Title
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Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study

Conditions
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Delirium, Psychomotor Agitation, Substance Withdrawal Syndrome, Nicotine Replacement Therapy

Intervention / Treatment
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* Drug: Transdermal nicotine patch
* Other: Cutaneous patch, containing no active substances


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine patch<br> | Drug: Transdermal nicotine patch<br>* 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.<br>* Other names: Nicotinell patch, regulated delivery 52.5 mg. RVG 14831;|
| Placebo Comparator: Control patch<br>The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances. | Other: Cutaneous patch, containing no active substances<br>* During the study period of thirty (30) days, the control product will be applicated daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Mortality |  | 30 days | 
| Patient Location Day 30 | In the ICU or hospital at day 30 | On day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day Mortality | Mortality at day 90 after enrollment | Day 90 followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Psychomotor Agitation, Substance Withdrawal Syndrome, Nicotine replacement therapy