Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT01362959
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2011-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Replacement Therapy in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'h.vandenoever@dz.nl', 'phone': '+31 570 535346', 'title': 'Dr. Huub van den Oever', 'organization': 'Department of Intensive care, Deventer Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Pilot study, therefore small numbers'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotine Replacement', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'deathsNumAffected': 2, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Electrolyte disturbance', 'notes': 'Any type of electrolyte distubance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 36, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 49, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal event', 'notes': 'Any type of gastrointestinal upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 40, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'notes': 'Any type of cardiac or circulatory event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 43, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'notes': 'Any type of pulmonary event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'notes': 'Any type of renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other adverse events', 'notes': 'Any other type of adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death due to respiratory failure', 'notes': 'Respiratory failure, hypoxaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to hypercapnic coma', 'notes': 'Hypercarbia due to type II respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemothorax', 'notes': 'Blood in the thoracic cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reintubation', 'notes': 'Need for reintubation after extubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to septic shock', 'notes': 'Respiratory sepsis, leading to death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'haemorrhagic shock', 'notes': 'Shock due to severe hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stoma necrosis', 'notes': 'Necrosis of colostoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal perforation', 'notes': 'Perforation of duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic colitis', 'notes': 'Ischaemic disease of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asystole', 'notes': 'Absence of cardiac rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Location Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On day 30', 'description': 'In the ICU or hospital at day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '90-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90 followup', 'description': 'Mortality at day 90 after enrollment', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Time in Normal Brain Function D20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000', 'lowerLimit': '316', 'upperLimit': '448'}, {'value': '304', 'groupId': 'OG001', 'lowerLimit': '110', 'upperLimit': '432'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '20 days', 'description': 'Time spent alive without delirium and without sedation or coma', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Time in Normal Brain Function D10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Replacement'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '216'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '210'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 days', 'description': 'Time alive without delirium and without sedation or coma', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Patch', 'description': 'Transdermal nicotine patch: The test product is a transdermal nicotine patch. The dose 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 applied daily.'}, {'id': 'FG001', 'title': 'Control Patch', 'description': 'The control product is a look-alike cutaneous patch comparable to the test product, containing no nicotine or other active substances. During the study period of thirty (30) days, the control product will be applied daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Patch', 'description': '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 applied daily.'}, {'id': 'BG001', 'title': 'Control Patch', 'description': 'The control product is a look-alike cutaneous patch comparable to the test product, containing no nicotine or other active substances. During the study period of thirty (30) days, the control product will be applied daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '10.55', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '9.13', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-03', 'studyFirstSubmitDate': '2011-05-26', 'resultsFirstSubmitDate': '2018-03-03', 'studyFirstSubmitQcDate': '2011-05-27', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-03', 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day Mortality', 'timeFrame': '30 days'}, {'measure': 'Patient Location Day 30', 'timeFrame': 'On day 30', 'description': 'In the ICU or hospital at day 30'}], 'secondaryOutcomes': [{'measure': '90-day Mortality', 'timeFrame': 'Day 90 followup', 'description': 'Mortality at day 90 after enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delirium', 'Psychomotor Agitation', 'Substance Withdrawal Syndrome', 'Nicotine replacement therapy'], 'conditions': ['Delirium', 'Psychomotor Agitation', 'Substance Withdrawal Syndrome', 'Nicotine Replacement Therapy']}, 'referencesModule': {'references': [{'pmid': '21142259', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17189035', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20554984', 'type': 'BACKGROUND', 'citation': 'Benowitz NL. Nicotine addiction. N Engl J Med. 2010 Jun 17;362(24):2295-303. doi: 10.1056/NEJMra0809890. No abstract available.'}, {'pmid': '18555914', 'type': 'BACKGROUND', 'citation': 'Hatsukami DK, Stead LF, Gupta PC. Tobacco addiction. Lancet. 2008 Jun 14;371(9629):2027-38. doi: 10.1016/S0140-6736(08)60871-5.'}, {'pmid': '20626883', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20380688', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11502936', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10470572', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17452926', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19567657', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20949331', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21494111', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18538699', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21368740', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20935560', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29881956', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.geldersevallei.nl', 'label': 'Website Gelderse Vallei Hospital'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nFurthermore, 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.\n\nRetrospective studies found a higher, lower or equal mortality in critically ill patients receiving nicotine replacement therapy compared to patients receiving no nicotine replacement.\n\nBecause 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Any patient admitted to the intensive care unit must meet all of the following criteria to be eligible for the study:\n\n* Critically ill active smoking patient\n* Being mechanically ventilated\n* Start of study product application within 48 hours after ICU admission\n* Expected to be mechanically ventilated for more than 48 hours after start of application of the study product\n\nExclusion Criteria: Any patient admitted to the intensive care unit meeting one or more of the following criteria is not eligible for the study:\n\n* Patient younger than 18 years\n* Patient or next of kin denying research authorization\n* Pregnancy\n* Breastfeeding women\n* History of chronic dementia or psychosis\n* (Acute) neurologic disease on admission, possibly confounding study objectives (TBI, stroke, ICH/SAH, seizures, meningitis, encephalitis, intracranial tumor)\n* Patient receiving any form of NRT within two weeks before admission\n* Patient not understanding Dutch\n* Patient with acute myocardial infarction\n* Patient with severe cardiac arrhythmia\n* Patient with unstable or deteriorating angina pectoris\n* Patient with generalized acute or chronic skin diseases interfering with NRT absorption\n* Patient with severe hearing deficiency\n* Moribund patient\n* Patient with known hypersensibility to nicotine or components of the transdermal therapeutic system\n* Patient with known hypersensibility to patches\n* Patient participating in an other study'}, 'identificationModule': {'nctId': 'NCT01362959', 'acronym': 'NicGoWell', 'briefTitle': 'Nicotine Replacement Therapy in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Gelderse Vallei Hospital'}, 'officialTitle': 'Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'NicGoWell1.0'}, 'secondaryIdInfos': [{'id': '2011-002458-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine patch', 'interventionNames': ['Drug: Transdermal nicotine patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control patch', 'description': 'The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.', 'interventionNames': ['Other: Cutaneous patch, containing no active substances']}], 'interventions': [{'name': 'Transdermal nicotine patch', 'type': 'DRUG', 'otherNames': ['Nicotinell patch, regulated delivery 35 mg. RVG 14830', 'Nicotinell patch, regulated delivery 52.5 mg. RVG 14831'], 'description': '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.', 'armGroupLabels': ['Nicotine patch']}, {'name': 'Cutaneous patch, containing no active substances', 'type': 'OTHER', 'description': 'During the study period of thirty (30) days, the control product will be applicated daily.', 'armGroupLabels': ['Control patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6716 RP', 'city': 'Ede', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Gelderse Vallei Hospital', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '7416 SE', 'city': 'Deventer', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Deventer Hospital', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}], 'overallOfficials': [{'name': 'Ben Jong,de, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gelderse Vallei Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gelderse Vallei Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deventer Ziekenhuis', 'class': 'OTHER'}, {'name': 'Wageningen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'drs. B. de Jong', 'investigatorAffiliation': 'Gelderse Vallei Hospital'}}}}