Nicotine Replacement Therapy in the Intensive Care Unit

Delirium Clinical Trial

— NicGoWell  

Official title:

Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362959
• Other study ID #: NicGoWell1.0
• Secondary ID: 2011-002458-29
• Status: Completed
• Phase: Phase 4
• Start date: June 2012
• Est. completion date: August 2016

Study information

• Verified date: March 2018
• Source: Gelderse Vallei Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Delirium
• Nicotine Replacement Therapy
• Psychomotor Agitation
• Substance Withdrawal Syndrome

Intervention

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.

Other:
• Cutaneous patch, containing no active substances
During the study period of thirty (30) days, the control product will be applicated daily.

Locations

Country	Name	City	State
Netherlands	Deventer Hospital	Deventer	Overijssel
Netherlands	Gelderse Vallei Hospital	Ede	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Gelderse Vallei Hospital	Deventer Ziekenhuis, Wageningen University

Country where clinical trial is conducted

Netherlands, 

References & Publications (15)

Benowitz NL. Nicotine addiction. N Engl J Med. 2010 Jun 17;362(24):2295-303. doi: 10.1056/NEJMra0809890. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. Erratum in: Am J Infect Control. 2008 Nov;36(9):655. — View 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. — View 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. — View 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. — View 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. — View 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;8:8. doi: 10.1186/1617-9625-8-8. — View Citation

Moreno R, Vincent JL, Matos R, Mendonça 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. — View Citation

Moss M, Burnham EL. Alcohol abuse in the critically ill patient. Lancet. 2006 Dec 23;368(9554):2231-42. Review. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day Mortality		30 days
Primary	Patient Location Day 30	In the ICU or hospital at day 30	On day 30
Secondary	90-day Mortality	Mortality at day 90 after enrollment	Day 90 followup

External Links

•   Website Gelderse Vallei Hospital