Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)
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|ClinicalTrials.gov Identifier: NCT01362959|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : August 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Delirium Psychomotor Agitation Substance Withdrawal Syndrome Nicotine Replacement Therapy||Drug: Transdermal nicotine patch Other: Cutaneous patch, containing no active substances||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
|Experimental: Nicotine patch||
Drug: Transdermal nicotine patch
The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applicated daily.
Placebo Comparator: Control patch
The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
Other: Cutaneous patch, containing no active substances
During the study period of thirty (30) days, the control product will be applicated daily.
- In-hospital mortality [ Time Frame: 30 days ]
- 30-day mortality [ Time Frame: On day 30 ]Last day study period
- 90-day mortality [ Time Frame: Day 90 followup ]
- Patient location [ Time Frame: On day 30, day 90 followup ]
- Total maximum SOFA score [ Time Frame: 30 days ]summing worst scores for each organ system
- Delta SOFA score [ Time Frame: 30 days ]total maximum SOFA score minus admission total SOFA score
- Mean RASS-score [ Time Frame: 30 days ]
- Highest RASS-score [ Time Frame: 30 days ]
- Lowest RASS-score [ Time Frame: 30 days ]
- Hours RASS-score outside optimal range (<-3 and/or >+1) [ Time Frame: 30 days ]
- Hours RASS-score outside optimal range (<-3 and/or >+1) indexed by the overall duration of sedation [ Time Frame: 30 days ]
- Hours with delirium [ Time Frame: 30 days ]
- Number of self-extubations [ Time Frame: 30 days ]
- Number of self-removed catheters [ Time Frame: 30 days ]
- Number of new nosocomial infections (CDC criteria) [ Time Frame: 30 days ]
- Total dose of sedatives, analgesics and antipsychotics in mg or μg/kg [ Time Frame: 30 days ]
- Hours of physical restraint [ Time Frame: 30 days ]
- Sedation-free hours [ Time Frame: 30 days ]
- Length of stay, ICU (hours) [ Time Frame: 30 days, day 90 followup ]
- Length of stay, hospital (hours) [ Time Frame: 30 days, day 90 followup ]
- Intensive Care Unit mortality [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362959
|Gelderse Vallei Hospital|
|Ede, Gelderland, Netherlands, 6716 RP|
|Deventer, Overijssel, Netherlands, 7416 SE|
|Principal Investigator:||Ben Jong,de, MD||Gelderse Vallei Hospital|