Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Gelderse Vallei Hospital
Sponsor:
Collaborators:
Deventer Ziekenhuis
Wageningen University
Information provided by (Responsible Party):
drs. B. de Jong, Gelderse Vallei Hospital
ClinicalTrials.gov Identifier:
NCT01362959
First received: May 26, 2011
Last updated: May 12, 2014
Last verified: May 2014

May 26, 2011
May 12, 2014
June 2012
June 2016   (final data collection date for primary outcome measure)
  • In-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 30-day mortality [ Time Frame: On day 30 ] [ Designated as safety issue: No ]
    Last day study period
  • 90-day mortality [ Time Frame: Day 90 followup ] [ Designated as safety issue: No ]
  • Patient location [ Time Frame: On day 30, day 90 followup ] [ Designated as safety issue: No ]
  • Total maximum SOFA score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    summing worst scores for each organ system
  • Delta SOFA score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    total maximum SOFA score minus admission total SOFA score
  • Mean RASS-score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Highest RASS-score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Lowest RASS-score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hours RASS-score outside optimal range (<-3 and/or >+1) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hours RASS-score outside optimal range (<-3 and/or >+1) indexed by the overall duration of sedation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hours with delirium [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of self-extubations [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of self-removed catheters [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of new nosocomial infections (CDC criteria) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total dose of sedatives, analgesics and antipsychotics in mg or μg/kg [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hours of physical restraint [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Sedation-free hours [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of stay, ICU (hours) [ Time Frame: 30 days, day 90 followup ] [ Designated as safety issue: No ]
  • Length of stay, hospital (hours) [ Time Frame: 30 days, day 90 followup ] [ Designated as safety issue: No ]
  • Intensive Care Unit mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01362959 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nicotine Replacement Therapy in the Intensive Care Unit
Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Delirium
  • Psychomotor Agitation
  • Substance Withdrawal Syndrome
  • Nicotine Replacement Therapy
  • 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 Names:
    • Nicotinell patch, regulated delivery 35 mg. RVG 14830
    • Nicotinell patch, regulated delivery 52.5 mg. RVG 14831
  • Other: Cutaneous patch, containing no active substances
    During the study period of thirty (30) days, the control product will be applicated daily.
  • Experimental: Nicotine patch
    Not applicable
    Intervention: Drug: Transdermal nicotine patch
  • Placebo Comparator: Control patch
    The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
    Intervention: Other: Cutaneous patch, containing no active substances

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ben Jong,de, MD +31646142070 benjongde@gmail.com
Contact: A.R.H. Zanten,van, MD, PhD +31318434114 zantenA@zgv.nl
Netherlands
 
NCT01362959
NicGoWell1.0, 2011-002458-29
Yes
drs. B. de Jong, Gelderse Vallei Hospital
Gelderse Vallei Hospital
  • Deventer Ziekenhuis
  • Wageningen University
Principal Investigator: Ben Jong,de, MD Gelderse Vallei Hospital
Gelderse Vallei Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP