Trial Outcomes & Findings for Nicotine Replacement Therapy in the Intensive Care Unit (NCT NCT01362959)
NCT ID: NCT01362959
Last Updated: 2018-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
30 days
Results posted on
2018-10-10
Participant Flow
Participant milestones
| Measure |
Nicotine Patch
Transdermal nicotine patch: The test product is a transdermal nicotine patch. The dose of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applied daily.
|
Control Patch
The control product is a look-alike cutaneous patch comparable to the test product, containing no nicotine or other active substances. During the study period of thirty (30) days, the control product will be applied daily.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
26
|
|
Overall Study
COMPLETED
|
21
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Replacement Therapy in the Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Nicotine Patch
n=21 Participants
Transdermal nicotine patch: The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applied daily.
|
Control Patch
n=26 Participants
The control product is a look-alike cutaneous patch comparable to the test product, containing no nicotine or other active substances. During the study period of thirty (30) days, the control product will be applied daily.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 9.13 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Nicotine Replacement
n=21 Participants
|
Control
n=26 Participants
|
|---|---|---|
|
30-day Mortality
|
9.5 percentage of patients
|
7.7 percentage of patients
|
PRIMARY outcome
Timeframe: On day 30In the ICU or hospital at day 30
Outcome measures
| Measure |
Nicotine Replacement
n=21 Participants
|
Control
n=26 Participants
|
|---|---|---|
|
Patient Location Day 30
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 90 followupMortality at day 90 after enrollment
Outcome measures
| Measure |
Nicotine Replacement
n=21 Participants
|
Control
n=26 Participants
|
|---|---|---|
|
90-day Mortality
|
14.3 percentage of patients
|
19.2 percentage of patients
|
POST_HOC outcome
Timeframe: 20 daysTime spent alive without delirium and without sedation or coma
Outcome measures
| Measure |
Nicotine Replacement
n=21 Participants
|
Control
n=26 Participants
|
|---|---|---|
|
Time in Normal Brain Function D20
|
400 hours
Interval 316.0 to 448.0
|
304 hours
Interval 110.0 to 432.0
|
POST_HOC outcome
Timeframe: 10 daysTime alive without delirium and without sedation or coma
Outcome measures
| Measure |
Nicotine Replacement
n=21 Participants
|
Control
n=26 Participants
|
|---|---|---|
|
Time in Normal Brain Function D10
|
160 hours
Interval 96.0 to 216.0
|
88 hours
Interval 20.0 to 210.0
|
Adverse Events
Nicotine Replacement
Serious events: 4 serious events
Other events: 21 other events
Deaths: 2 deaths
Control
Serious events: 11 serious events
Other events: 26 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nicotine Replacement
n=21 participants at risk
|
Control
n=26 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death due to respiratory failure
|
4.8%
1/21 • Number of events 1 • 30 days
|
7.7%
2/26 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Death due to hypercapnic coma
|
4.8%
1/21 • Number of events 1 • 30 days
|
0.00%
0/26 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
4.8%
1/21 • Number of events 1 • 30 days
|
0.00%
0/26 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Reintubation
|
4.8%
1/21 • Number of events 1 • 30 days
|
7.7%
2/26 • Number of events 2 • 30 days
|
|
Infections and infestations
Death due to septic shock
|
0.00%
0/21 • 30 days
|
3.8%
1/26 • Number of events 1 • 30 days
|
|
Vascular disorders
haemorrhagic shock
|
0.00%
0/21 • 30 days
|
3.8%
1/26 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Stoma necrosis
|
0.00%
0/21 • 30 days
|
3.8%
1/26 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/21 • 30 days
|
3.8%
1/26 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Ischaemic colitis
|
0.00%
0/21 • 30 days
|
7.7%
2/26 • Number of events 2 • 30 days
|
|
Cardiac disorders
Asystole
|
0.00%
0/21 • 30 days
|
3.8%
1/26 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Nicotine Replacement
n=21 participants at risk
|
Control
n=26 participants at risk
|
|---|---|---|
|
Investigations
Electrolyte disturbance
|
100.0%
21/21 • Number of events 36 • 30 days
|
100.0%
26/26 • Number of events 49 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal event
|
100.0%
21/21 • Number of events 27 • 30 days
|
100.0%
26/26 • Number of events 40 • 30 days
|
|
Cardiac disorders
Cardiovascular
|
76.2%
16/21 • Number of events 16 • 30 days
|
100.0%
26/26 • Number of events 43 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
23.8%
5/21 • Number of events 5 • 30 days
|
30.8%
8/26 • Number of events 8 • 30 days
|
|
Renal and urinary disorders
Renal
|
4.8%
1/21 • Number of events 1 • 30 days
|
23.1%
6/26 • Number of events 6 • 30 days
|
|
General disorders
Other adverse events
|
81.0%
17/21 • Number of events 17 • 30 days
|
100.0%
26/26 • Number of events 31 • 30 days
|
Additional Information
Dr. Huub van den Oever
Department of Intensive care, Deventer Hospital
Phone: +31 570 535346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place