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
  Purpose

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.


Condition Intervention Phase
Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine Replacement Therapy
Drug: Transdermal nicotine patch
Other: Cutaneous patch, containing no active substances
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Gelderse Vallei Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine patch
Not applicable
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
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362959

Contacts
Contact: Ben Jong,de, MD +31646142070 benjongde@gmail.com
Contact: A.R.H. Zanten,van, MD, PhD +31318434114 zantenA@zgv.nl

Locations
Netherlands
Gelderse Vallei Hospital Recruiting
Ede, Gelderland, Netherlands, 6716 RP
Contact: Ben Jong,de, MD    +31318434114    benjongde@gmail.com   
Contact: A.R.H. Zanten,van, MD,PhD    +31318434114    zantena@zgv.nl   
Principal Investigator: Ben Jong,de, MD         
Sub-Investigator: A.R.H. Zanten,van, MD, PhD         
Deventer Hospital Recruiting
Deventer, Overijssel, Netherlands, 7416 SE
Contact: van den Oever, MD       H.vandenOever@dz.nl   
Sub-Investigator: Huub van den Oever, MD         
Sponsors and Collaborators
Gelderse Vallei Hospital
Deventer Ziekenhuis
Wageningen University
Investigators
Principal Investigator: Ben Jong,de, MD Gelderse Vallei Hospital
  More Information

Additional Information:
Publications:

Responsible Party: drs. B. de Jong, MD, Gelderse Vallei Hospital
ClinicalTrials.gov Identifier: NCT01362959     History of Changes
Other Study ID Numbers: NicGoWell1.0, 2011-002458-29
Study First Received: May 26, 2011
Last Updated: May 12, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Gelderse Vallei Hospital:
Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine replacement therapy

Additional relevant MeSH terms:
Delirium
Syndrome
Substance Withdrawal Syndrome
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Dyskinesias
Psychomotor Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014