icotine Replacement Therapy in the Intensive Care Unit: a randomized, controlled pilot study.

Phase 4

Completed

• Conditions: icotine ontwenning; 10012221; Nicotine withdrawal; tobacco withdrawal

• Registration Number: NL-OMON39987
• Lead Sponsor: Ziekenhuisvoorzieningen Gelderse Vallei

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-08-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 47

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 aritmia;- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- 30-day mortality</p><br>