Prevention of nicotine abstinence symptoms in critically ill patients

Phase 1

• Conditions: icotin abstinence delirium; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-003720-43-CZ
• Lead Sponsor: Fakultní nemocnice Ostrava

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients older than 18 years.
• Patients with the assumption of nicotine abstinence. Prerequisite sudden nicotine abstinence as a risk factor for development of delirium will be assessed by the Test for Nicotine Dependence according to the Fagerstrom. The questionnaire will be filled by the patient within medical examination before anesthesia.

• Patients included in the group of patients undergoing major surgery within the abdominal region, urology and thoracic surgery and to subsequent ICU clinics KARIM FNO> 48 hours. Presumption of hospitalization in the ICU clinics KARIM FNO> 48 hours will be determined based on the prediction of the medical assessment.

• Obtaining informed consent (signed and dated) approved MEK.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Age <18 years.
• failure to obtain informed consent approved by the Ethics Committee.
• Patients undergoing neurosurgical operation, patients diagnosed with cranial trauma.
• Patients diagnosed with psychiatric illness.
• Known allergy to nicotine or any other component of the transdermal patch NiQuitin CLEAR 21 mg.
• Known allergy to surgical bandage Curapor.
• patients with recent heart attack, unstable or worsening angina or patients with serious heart rhythm disorders, patients with a fresh stroke.
• Pregnant and nursing women.
• Patients with concomitant treatment with products containing nicotine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: The secondary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with the assumption of nicotine abstinence is associated with shorter duration of mechanical ventilation in these patients.;Primary end point(s): The primary efficacy endpoint (primary endpoint) to achieve a statistically significant (significance level p = 0.05) reduction in the incidence of delirium in the group of patients with the application of the study drug. ;Timepoint(s) of evaluation of this end point: When 100 patients complete study after 18 month.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy parameter (secondary endopoint) to achieve a statistically significant (significance level p = 0.05) reduction of the number of hours of mechanical ventilation in patients.;Timepoint(s) of evaluation of this end point: 18 month of Follow-uo