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Nicotine Replacement Therapy in the Intensive Care Unit (NicGoWell)

Primary Purpose

Delirium, Psychomotor Agitation, Substance Withdrawal Syndrome

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Transdermal nicotine patch
Cutaneous patch, containing no active substances
Sponsored by
Gelderse Vallei Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Psychomotor Agitation, Substance Withdrawal Syndrome, Nicotine replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gelderse Vallei Hospital
  • Deventer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotine patch

Control patch

Arm Description

The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.

Outcomes

Primary Outcome Measures

30-day Mortality
Patient Location Day 30
In the ICU or hospital at day 30

Secondary Outcome Measures

90-day Mortality
Mortality at day 90 after enrollment

Full Information

First Posted
May 26, 2011
Last Updated
March 3, 2018
Sponsor
Gelderse Vallei Hospital
Collaborators
Deventer Ziekenhuis, Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT01362959
Brief Title
Nicotine Replacement Therapy in the Intensive Care Unit
Acronym
NicGoWell
Official Title
Nicotine Replacement Therapy in the Intensive Care Unit: a Randomized, Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gelderse Vallei Hospital
Collaborators
Deventer Ziekenhuis, Wageningen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Psychomotor Agitation, Substance Withdrawal Syndrome, Nicotine Replacement Therapy
Keywords
Delirium, Psychomotor Agitation, Substance Withdrawal Syndrome, Nicotine replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine patch
Arm Type
Experimental
Arm Title
Control patch
Arm Type
Placebo Comparator
Arm Description
The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
Intervention Type
Drug
Intervention Name(s)
Transdermal nicotine patch
Other Intervention Name(s)
Nicotinell patch, regulated delivery 35 mg. RVG 14830, Nicotinell patch, regulated delivery 52.5 mg. RVG 14831
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Cutaneous patch, containing no active substances
Intervention Description
During the study period of thirty (30) days, the control product will be applicated daily.
Primary Outcome Measure Information:
Title
30-day Mortality
Time Frame
30 days
Title
Patient Location Day 30
Description
In the ICU or hospital at day 30
Time Frame
On day 30
Secondary Outcome Measure Information:
Title
90-day Mortality
Description
Mortality at day 90 after enrollment
Time Frame
Day 90 followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Jong,de, MD
Organizational Affiliation
Gelderse Vallei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gelderse Vallei Hospital
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6716 RP
Country
Netherlands
Facility Name
Deventer Hospital
City
Deventer
State/Province
Overijssel
ZIP/Postal Code
7416 SE
Country
Netherlands

12. IPD Sharing Statement

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Links:
URL
http://www.geldersevallei.nl
Description
Website Gelderse Vallei Hospital

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Nicotine Replacement Therapy in the Intensive Care Unit

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