Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

NCT03847155 | Completed

• 2 other identifiers: KARIM-09-NICOTINE2014-003720-43
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Keywords

nicotine patch; placebo; critically ill patients; delirium; prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  maximum of 7 days

Secondary Outcomes (2)

• Change in the number of days with delirium

  maximum of 7 days

• Ventilator-hours

  maximum of 7 days

Study Arms (2)

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.

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.

Other: Placebo patch

Interventions

Nicotine patch DRUG

The patients will receive a nicotine patch for the period of a maximum of 7 days.

Nicotine

Placebo patch OTHER

The patients will receive a placebo patch for the period of a maximum of 7 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (5)

• 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.

  PMID: 12059899 BACKGROUND

• Bledowski 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.

  PMID: 22480622 BACKGROUND

• Cartin-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.

  PMID: 21494111 BACKGROUND

• Jablonski 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.

  PMID: 28375992 BACKGROUND

• Van 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.

  PMID: 18282269 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Delirium

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jan Neiser, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participant, care provider and investigator will be masked as far as the treatment provided is concerned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized into two study groups, with the active substance and placebo.

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: September 23, 2015
• Primary Completion: January 31, 2021
• Study Completion: February 8, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)