Nicotine Replacement Therapy in the Intensive Care Unit

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gelderse Vallei Hospital
• Collaborators: Deventer Ziekenhuis; Wageningen University
• Treatments: Nicotine

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