Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

February 8, 2021 updated by: University Hospital Ostrava
The primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients in a group with medical intervention receive nicotine patch within 24 hours after surgery. The nicotine patch is replaced every day. Delirium is evaluated every day by the Confusion Assessment Method (CAM) - ICU test. The maximum length of intervention is 7 days.

Patients in a group with placebo receive a placebo patch within 24 hours after surgery. This patch is replaced every day. Delirium is evaluated in the same way - CAM - ICU test. The maximum length of the placebo intervention is 7 days.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing a surgical procedure - urological, surgical, trauma surgery, orthopedic surgery, dental surgery)
  • Age 18 years and above
  • Patient with an assumption of nicotine abstinence (smoking a minimum 10 cigarettes/day).
  • Ex-smokers (if they stopped smoking less than 30 days prior to surgery)
  • An assumption of hospitalization at the intensive care unit (ICU) after surgery
  • Signed Informed consent

Exclusion Criteria:

  • Age ˂ 18 years
  • Non-signing of the informed consent
  • Patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke
  • Patients with psychiatric diseases
  • Nicotine, Curapor or Hydrocoll allergy
  • Patient with a heart attack, unstable angina pectoris or patients with a serious heart arrhythmia
  • Pregnant and breastfeeding patients
  • Patients with nicotine treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nicotine
The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.
Drug: Nicotine patch
The patients will receive a nicotine patch for the period of a maximum of 7 days.
PLACEBO_COMPARATOR: Placebo
The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.
Other: Placebo patch
The patients will receive a placebo patch for the period of a maximum of 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium episodes
Time Frame: maximum of 7 days
The number of delirium episodes, defined according to the CAM-ICU test, in the course of the seven days with the patch attached will be measured in both groups of study subjects.
maximum of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of days with delirium
Time Frame: maximum of 7 days
Change in the number of days with delirium, defined according to the CAM-ICU test, by 20%, in the course of the seven days with the patch attached among the study subjects with the nicotine patch.
maximum of 7 days
Ventilator-hours
Time Frame: maximum of 7 days
The number of ventilator-hours will be observed in both groups of study subjects.
maximum of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Jan Neiser, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2015

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

February 8, 2021

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (ACTUAL)

February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KARIM-09-NICOTINE
  • 2014-003720-43 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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