Trial Outcomes & Findings for Cerebral Perfusion Pressure Using Precedex and Other Sedatives (NCT NCT01169467)
NCT ID: NCT01169467
Last Updated: 2015-11-02
Results Overview
Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
COMPLETED
PHASE3
89 participants
Baseline to 24 hours
2015-11-02
Participant Flow
89 subject signed consent, 5 subjects screen failed.
Participant milestones
| Measure |
Standard-of-Care Plus Precedex
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
40
|
|
Overall Study
COMPLETED
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Baseline characteristics by cohort
| Measure |
Standard-of-Care Plus Precedex
n=44 Participants
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=40 Participants
Subjects who are treated with the standard of care sedation regiment only.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursPopulation: Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.
Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
Outcome measures
| Measure |
Standard-of-Care Plus Precedex
n=34 Participants
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=25 Participants
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
Variability of Intracranial Pressure (ICP)
|
5.66 mmHg
Standard Error 0.63
|
5.61 mmHg
Standard Error 0.64
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursPopulation: Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis.
Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP). A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.
Outcome measures
| Measure |
Standard-of-Care Plus Precedex
n=32 Participants
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=22 Participants
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
Change in Pressure Reactivity Index (PRx)
|
.64 Pressure Reactivity Index
Standard Error .02
|
.66 Pressure Reactivity Index
Standard Error .02
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis.
Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.
Outcome measures
| Measure |
Standard-of-Care Plus Precedex
n=44 Participants
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=39 Participants
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury
|
155.4 mg/ml
Standard Error 23.3
|
213.1 mg/ml
Standard Error 26.3
|
SECONDARY outcome
Timeframe: Baseline to 24 hoursPopulation: Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.
Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.
Outcome measures
| Measure |
Standard-of-Care Plus Precedex
n=34 Participants
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=25 Participants
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury
|
11.5 mmHg
Standard Error .63
|
12.3 mmHg
Standard Error .74
|
SECONDARY outcome
Timeframe: Baseline to 24 hoursPopulation: Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis.
Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.
Outcome measures
| Measure |
Standard-of-Care Plus Precedex
n=39 Participants
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=28 Participants
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury
|
12.30 mmHg
Standard Error 0.73
|
13.8 mmHg
Standard Error 1.44
|
Adverse Events
Standard-of-Care Plus Precedex
Standard-of-Care
Serious adverse events
| Measure |
Standard-of-Care Plus Precedex
n=44 participants at risk
Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
|
Standard-of-Care
n=40 participants at risk
Subjects who are treated with the standard of care sedation regiment only.
|
|---|---|---|
|
General disorders
Death (Withdrawal of Life Support)
|
2.3%
1/44 • Number of events 1
|
0.00%
0/40
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place