Clinical trial NCT01362959: Nicotine Replacement Therapy in the Intensive Care Unit
Official title: Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine Replacement Therapy
Keywords: Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine replacement therapy
Lead sponsor: Gelderse Vallei Hospital
Sponsor class: OTHER
Collaborators: name: Deventer Ziekenhuis
name: Wageningen University
First posted: 2011-06-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 30-day Mortality
timeFrame: 30 days
measure: Patient Location Day 30
timeFrame: On day 30
Secondary outcomes:
measure: 90-day Mortality
timeFrame: Day 90 followup
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: Gelderse Vallei Hospital
state: Gelderland
city: Deventer
country: Netherlands
facility: Deventer Hospital
state: Overijssel
Study officials:
affiliation: Gelderse Vallei Hospital
name: Ben Jong,de, MD
role: PRINCIPAL_INVESTIGATOR
References:
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