Nicotine Replacement Therapy in the Intensive Care Unit
NCT ID: NCT01362959
Last Updated: 2018-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
47 participants
INTERVENTIONAL
2012-06-30
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nicotine patch
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.
Control patch
The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
Cutaneous patch, containing no active substances
During the study period of thirty (30) days, the control product will be applicated daily.
Interventions
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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.
Cutaneous patch, containing no active substances
During the study period of thirty (30) days, the control product will be applicated daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Deventer Ziekenhuis
OTHER
Wageningen University
OTHER
Gelderse Vallei Hospital
OTHER
Responsible Party
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drs. B. de Jong
MD
Principal Investigators
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Ben Jong,de, MD
Role: PRINCIPAL_INVESTIGATOR
Gelderse Vallei Hospital
Locations
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Gelderse Vallei Hospital
Ede, Gelderland, Netherlands
Deventer Hospital
Deventer, Overijssel, Netherlands
Countries
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References
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Hays JT, Ebbert JO. Adverse effects and tolerability of medications for the treatment of tobacco use and dependence. Drugs. 2010 Dec 24;70(18):2357-72. doi: 10.2165/11538190-000000000-00000.
Moss M, Burnham EL. Alcohol abuse in the critically ill patient. Lancet. 2006 Dec 23;368(9554):2231-42. doi: 10.1016/S0140-6736(06)69490-7.
Benowitz NL. Nicotine addiction. N Engl J Med. 2010 Jun 17;362(24):2295-303. doi: 10.1056/NEJMra0809890. No abstract available.
Hatsukami DK, Stead LF, Gupta PC. Tobacco addiction. Lancet. 2008 Jun 14;371(9629):2027-38. doi: 10.1016/S0140-6736(08)60871-5.
Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis. 2010 Jul 13;8(1):8. doi: 10.1186/1617-9625-8-8.
Lucidarme O, Seguin A, Daubin C, Ramakers M, Terzi N, Beck P, Charbonneau P, du Cheyron D. Nicotine withdrawal and agitation in ventilated critically ill patients. Crit Care. 2010;14(2):R58. doi: 10.1186/cc8954. Epub 2010 Apr 9.
Mayer SA, Chong JY, Ridgway E, Min KC, Commichau C, Bernardini GL. Delirium from nicotine withdrawal in neuro-ICU patients. Neurology. 2001 Aug 14;57(3):551-3. doi: 10.1212/wnl.57.3.551.
Moreno R, Vincent JL, Matos R, Mendonca A, Cantraine F, Thijs L, Takala J, Sprung C, Antonelli M, Bruining H, Willatts S. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems of the ESICM. Intensive Care Med. 1999 Jul;25(7):686-96. doi: 10.1007/s001340050931.
Lee AH, Afessa B. The association of nicotine replacement therapy with mortality in a medical intensive care unit. Crit Care Med. 2007 Jun;35(6):1517-21. doi: 10.1097/01.CCM.0000266537.86437.38.
Paciullo CA, Short MR, Steinke DT, Jennings HR. Impact of nicotine replacement therapy on postoperative mortality following coronary artery bypass graft surgery. Ann Pharmacother. 2009 Jul;43(7):1197-202. doi: 10.1345/aph.1L423. Epub 2009 Jun 30.
Seder DB, Schmidt JM, Badjatia N, Fernandez L, Rincon F, Claassen J, Gordon E, Carrera E, Kurtz P, Lee K, Connolly ES, Mayer SA. Transdermal nicotine replacement therapy in cigarette smokers with acute subarachnoid hemorrhage. Neurocrit Care. 2011 Feb;14(1):77-83. doi: 10.1007/s12028-010-9456-9.
Cartin-Ceba R, Warner DO, Hays JT, Afessa B. Nicotine replacement therapy in critically ill patients: a prospective observational cohort study. Crit Care Med. 2011 Jul;39(7):1635-40. doi: 10.1097/CCM.0b013e31821867b8.
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
Centers for Disease Control and Prevention (CDC). Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.
Hsieh SJ, Ware LB, Eisner MD, Yu L, Jacob P 3rd, Havel C, Goniewicz ML, Matthay MA, Benowitz NL, Calfee CS. Biomarkers increase detection of active smoking and secondhand smoke exposure in critically ill patients. Crit Care Med. 2011 Jan;39(1):40-5. doi: 10.1097/CCM.0b013e3181fa4196.
de Jong B, Schuppers AS, Kruisdijk-Gerritsen A, Arbouw MEL, van den Oever HLA, van Zanten ARH. The safety and efficacy of nicotine replacement therapy in the intensive care unit: a randomised controlled pilot study. Ann Intensive Care. 2018 Jun 7;8(1):70. doi: 10.1186/s13613-018-0399-1.
Related Links
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Website Gelderse Vallei Hospital
Other Identifiers
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2011-002458-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NicGoWell1.0
Identifier Type: -
Identifier Source: org_study_id
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