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Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery

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ClinicalTrials.gov Identifier: NCT02918500
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicoderm Patch Phase 4

Detailed Description:

The aim of this project is to

  1. To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.
  2. To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.
  3. To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.

We therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications

To assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Placebo
Participants will receive 3 weeks of inactive NRT patches.
Active Comparator: Active
Participants will receive 3 weeks of active NRT patches
Drug: Nicoderm Patch
Nicotine replacement therapy patch




Primary Outcome Measures :
  1. Carbon monoxide (CO) confirmed abstinence at the time of surgery [ Time Frame: At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op) ]
    To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery


Secondary Outcome Measures :
  1. The effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery [ Time Frame: At the time of surgery and each follow up visit (1 & 6 months post-op) ]
    Measured by the perceived stress scale (PSS-14)


Other Outcome Measures:
  1. The impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay. [ Time Frame: assessed at the 1 and 6 month post-op follow up visits ]
    Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is currently smoking >5 cigarettes/day for the past 30 days; there is no evidence that NRT is useful in those who smoke <5cpd.
  2. Patient is able to participate and willing to provide informed consent; participants will need to follow directions and adhere to the medication usage instructions as outlined in the informed consent document.
  3. Patients is willing to be contacted by phone for follow up at 1 month and 6 months post-discharge; these time points will assess our final outcome of cessation at 6 months post-discharge.

Exclusion Criteria:

  1. Patient is scheduled for surgery in < 7 days; most patients need to be using NRT consistently for 2 weeks for it to be fully effective.
  2. Patient is currently using a smoking cessation product (i.e. nicotine containing patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette, varenicline, buproprion) or has used a smoking cessation aid consistently for more than 72 consecutive hours with the intent to reduce cigarette consumption or quit smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will ensure the effects of the study patches will be assessed without any contamination from other cessation products.
  3. Patient is willing to refrain from using any other cessation products (nicotine containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the usage and side effects with the study patches.
  4. Patient is allergic to the adhesive on the nicotine replacement therapy patch.
  5. Patient is unable to read and understand English or French; study materials will only be supplied in these two languages.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918500


Contacts
Contact: Evyanne Wooding 613-696-7000 ext 17596 ewooding@ottawaheart.ca
Contact: Aaron Brautigam 613-696-7000 ext 14377

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Evyanne Wooding    613-696-7000 ext 17596    ewooding@ottawaheart.ca   
Contact: Aaron Brautigam    613-696-7000 ext 14377    abrautigam@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Andrew Pipe, MD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02918500     History of Changes
Other Study ID Numbers: 20160696-01H
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Heart Institute Research Corporation:
Coronary Artery Bypass Surgery (CABG)
Nicotine Replacement Therapy (NRT)

Additional relevant MeSH terms:
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