Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Patient Location Day 30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nicotine patch
干预措施: Transdermal nicotine patch (Drug)
Control patch
The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
干预措施: Cutaneous patch, containing no active substances (Other)
结局指标
主要结局
Patient Location Day 30
时间窗: On day 30
In the ICU or hospital at day 30
30-day Mortality
时间窗: 30 days
次要结局
- 90-day Mortality(Day 90 followup)
研究者
drs. B. de Jong
MD
Gelderse Vallei Hospital