Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)

Gelderse Vallei Hospital

Status and phase

Completed

Phase 4

Conditions

Psychomotor Agitation

Delirium

Substance Withdrawal Syndrome

Nicotine Replacement Therapy

Treatments

Other: Cutaneous patch, containing no active substances

Drug: Transdermal nicotine patch

Study type

Interventional

Funder types

Other

Identifiers

NCT01362959

NicGoWell1.0

2011-002458-29 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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