Nicotine Replacement Therapy in the Intensive Care Unit

Phase 4

Completed

Conditions: Nicotine Replacement Therapy
Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome

Interventions: Drug: Transdermal nicotine patch
Other: Cutaneous patch, containing no active substances

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nicotine patch	Transdermal nicotine patch	-
Control patch	Cutaneous patch, containing no active substances	The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.

Primary Outcome Measures