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Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)

This study has been completed.
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: August 26, 2016
Last verified: August 2016
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 drs. B. de Jong, Gelderse Vallei Hospital:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: 30 days ]
  • 30-day mortality [ Time Frame: On day 30 ]
    Last day study period

  • 90-day mortality [ Time Frame: Day 90 followup ]
  • Patient location [ Time Frame: On day 30, day 90 followup ]
  • Total maximum SOFA score [ Time Frame: 30 days ]
    summing worst scores for each organ system

  • Delta SOFA score [ Time Frame: 30 days ]
    total maximum SOFA score minus admission total SOFA score

  • Mean RASS-score [ Time Frame: 30 days ]
  • Highest RASS-score [ Time Frame: 30 days ]
  • Lowest RASS-score [ Time Frame: 30 days ]
  • Hours RASS-score outside optimal range (<-3 and/or >+1) [ Time Frame: 30 days ]
  • Hours RASS-score outside optimal range (<-3 and/or >+1) indexed by the overall duration of sedation [ Time Frame: 30 days ]
  • Hours with delirium [ Time Frame: 30 days ]
  • Number of self-extubations [ Time Frame: 30 days ]
  • Number of self-removed catheters [ Time Frame: 30 days ]
  • Number of new nosocomial infections (CDC criteria) [ Time Frame: 30 days ]
  • Total dose of sedatives, analgesics and antipsychotics in mg or μg/kg [ Time Frame: 30 days ]
  • Hours of physical restraint [ Time Frame: 30 days ]
  • Sedation-free hours [ Time Frame: 30 days ]
  • Length of stay, ICU (hours) [ Time Frame: 30 days, day 90 followup ]
  • Length of stay, hospital (hours) [ Time Frame: 30 days, day 90 followup ]
  • Intensive Care Unit mortality [ Time Frame: 30 days ]

Enrollment: 47
Study Start Date: June 2012
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine patch 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Netherlands
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands, 6716 RP
Deventer Hospital
Deventer, Overijssel, Netherlands, 7416 SE
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 ( EudraCT Number )
Study First Received: May 26, 2011
Last Updated: August 26, 2016

Keywords provided by drs. B. de Jong, Gelderse Vallei Hospital:
Delirium
Psychomotor Agitation
Substance Withdrawal Syndrome
Nicotine replacement therapy

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

ClinicalTrials.gov processed this record on September 21, 2017