Nicotine DependenceNCT03847155
Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
A study testing Nicotine patch in people with Nicotine Dependence, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Sep 2015to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Nicotine patch, Placebo patch
- Keywords
- nicotine patch, placebo, critically ill patients, delirium, prevention
- Medical subject headings
- Tobacco Use Disorder, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
The patients will receive a nicotine patch for the period of a maximum of 7 days.
Placebo patchOther
The patients will receive a placebo patch for the period of a maximum of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine | Experimental | The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days. Receives: Drug: Nicotine patch |
| Placebo | Placebo comparator | The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days. Receives: Other: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium episodes
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.
Measured: maximum of 7 days
Secondary outcomes (2)
Change in the number of days with delirium
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.
Measured: maximum of 7 days
Ventilator-hours
The number of ventilator-hours will be observed in both groups of study subjects.
Measured: maximum of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start23 Sep 2015
- Primary completion31 Jan 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized into two study groups, with the active substance and placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Neiser, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847155
- Sponsor's protocol ID
- KARIM-09-NICOTINE
- Other IDs
- 2014-003720-43, 2014
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to make individual participant data available to other researchers.
Publications
Granberg Axell AI, Malmros CW, Bergbom IL, Lundberg DB. Intensive care unit syndrome/delirium is associated with anemia, drug therapy and duration of ventilation treatment. Acta Anaesthesiol Scand. 2002 Jul;46(6):726-31. doi: 10.1034/j.1399-6576.2002.460616.x.
PubMed 12059899Bledowski J, Trutia A. A review of pharmacologic management and prevention strategies for delirium in the intensive care unit. Psychosomatics. 2012 May-Jun;53(3):203-11. doi: 10.1016/j.psym.2011.12.005. Epub 2012 Apr 4.
PubMed 22480622Cartin-Ceba R, Warner DO, Hays JT, Afessa B. Nicotine replacement therapy in critically ill patients: a prospective observational cohort study. Crit Care Med. 2011 Jul;39(7):1635-40. doi: 10.1097/CCM.0b013e31821867b8.
PubMed 21494111Jablonski J, Gray J, Miano T, Redline G, Teufel H, Collins T, Pascual-Lopez J, Sylvia M, Martin ND. Pain, Agitation, and Delirium Guidelines: Interprofessional Perspectives to Translate the Evidence. Dimens Crit Care Nurs. 2017 May/Jun;36(3):164-173. doi: 10.1097/DCC.0000000000000239.
PubMed 28375992Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. A comparison of the CAM-ICU and the NEECHAM Confusion Scale in intensive care delirium assessment: an observational study in non-intubated patients. Crit Care. 2008;12(1):R16. doi: 10.1186/cc6790. Epub 2008 Feb 18.
PubMed 18282269
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
- ClinicalTrials.gov ID
- NCT03847155
- Acronym / sponsor ID
- KARIM-09-NICOTINE
- Conditions
- Nicotine Dependence
- Keywords
- nicotine patch, placebo, critically ill patients, delirium, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The patients will be randomized into two study groups, with the active substance and placebo.
| Arm | Type | Receives |
|---|---|---|
| Nicotine | Experimental | Drug: Nicotine patchThe patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days. |
| Placebo | Placebo comparator | Other: Placebo patchThe patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchThe patients will receive a nicotine patch for the period of a maximum of 7 days. | Drug | Nicotine |
| Placebo patchThe patients will receive a placebo patch for the period of a maximum of 7 days. | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
Change in the number of days with delirium
Time frame: maximum of 7 days
Ventilator-hours
Time frame: maximum of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 12059899Granberg Axell AI, Malmros CW, Bergbom IL, Lundberg DB. Intensive care unit syndrome/delirium is associated with anemia, drug therapy and duration of ventilation treatment. Acta Anaesthesiol Scand. 2002 Jul;46(6):726-31. doi: 10.1034/j.1399-6576.2002.460616.x.
- Background: PubMed 22480622Bledowski J, Trutia A. A review of pharmacologic management and prevention strategies for delirium in the intensive care unit. Psychosomatics. 2012 May-Jun;53(3):203-11. doi: 10.1016/j.psym.2011.12.005. Epub 2012 Apr 4.
- Background: PubMed 21494111Cartin-Ceba R, Warner DO, Hays JT, Afessa B. Nicotine replacement therapy in critically ill patients: a prospective observational cohort study. Crit Care Med. 2011 Jul;39(7):1635-40. doi: 10.1097/CCM.0b013e31821867b8.
- Background: PubMed 28375992Jablonski J, Gray J, Miano T, Redline G, Teufel H, Collins T, Pascual-Lopez J, Sylvia M, Martin ND. Pain, Agitation, and Delirium Guidelines: Interprofessional Perspectives to Translate the Evidence. Dimens Crit Care Nurs. 2017 May/Jun;36(3):164-173. doi: 10.1097/DCC.0000000000000239.
- Background: PubMed 18282269Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. A comparison of the CAM-ICU and the NEECHAM Confusion Scale in intensive care delirium assessment: an observational study in non-intubated patients. Crit Care. 2008;12(1):R16. doi: 10.1186/cc6790. Epub 2008 Feb 18.
- Individual participant dataSharing planned: No. The investigators do not plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Neiser, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch in people with Nicotine Dependence, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium episodes (time frame: maximum of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847155, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.