Trial · NCT01169467
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
NCT01169467, Phase 3, Completed, Duke University; results first posted 2015-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cerebral Perfusion Pressure Using Precedex and Other Sedatives. Trials, record NCT01169467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01169467
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cerebral Perfusion Pressure Using Precedex and Other Sedatives
- NCT number
- NCT01169467
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 89 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Endotracheal Intubation, Continuous IV Sedation, ICP Monitoring
- Interventions
- Standard-of-Care plus Dexmedetomidine, Standard-of-Care
- First posted
- 2010-07-26
- Last updated
- 2015-11-02
- Results first posted
- 2015-11-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Variability of Intracranial Pressure (ICP) | Baseline to 24 hours | 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 |
| Primary | Change in Pressure Reactivity Index (PRx) | Baseline to 24 hours | 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. |
| Secondary | Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury | 24 hours | 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. |
| Secondary | Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury | Baseline to 24 hours | 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. |
| Secondary | Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury | Baseline to 24 hours | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Variability of Intracranial Pressure (ICP) | Baseline to 24 hours | Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis. | mmHg | MEAN |
| PRIMARY | Change in Pressure Reactivity Index (PRx) | Baseline to 24 hours | Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis. | Pressure Reactivity Index | MEAN |
| SECONDARY | Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury | 24 hours | Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis. | mg/ml | MEAN |
| SECONDARY | Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury | Baseline to 24 hours | Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis. | mmHg | MEAN |
| SECONDARY | Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury | Baseline to 24 hours | Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Variability of Intracranial Pressure (ICP) | Standard-of-Care Plus Precedex | 5.66 | Standard Error 0.63 | mmHg | |
| Variability of Intracranial Pressure (ICP) | Standard-of-Care | 5.61 | Standard Error 0.64 | mmHg | |
| Change in Pressure Reactivity Index (PRx) | Standard-of-Care Plus Precedex | .64 | Standard Error .02 | Pressure Reactivity Index | |
| Change in Pressure Reactivity Index (PRx) | Standard-of-Care | .66 | Standard Error .02 | Pressure Reactivity Index | |
| Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury | Standard-of-Care Plus Precedex | 155.4 | Standard Error 23.3 | mg/ml | |
| Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury | Standard-of-Care | 213.1 | Standard Error 26.3 | mg/ml | |
| Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury | Standard-of-Care Plus Precedex | 11.5 | Standard Error .63 | mmHg | |
| Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury | Standard-of-Care | 12.3 | Standard Error .74 | mmHg | |
| Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury | Standard-of-Care Plus Precedex | 12.30 | Standard Error 0.73 | mmHg | |
| Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury | Standard-of-Care | 13.8 | Standard Error 1.44 | mmHg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard-of-Care Plus Precedex | 44 | |
| Overall Study | STARTED | Standard-of-Care | 40 | |
| Overall Study | COMPLETED | Standard-of-Care Plus Precedex | 37 | |
| Overall Study | COMPLETED | Standard-of-Care | 36 | |
| Overall Study | NOT COMPLETED | Standard-of-Care Plus Precedex | 7 | |
| Overall Study | NOT COMPLETED | Standard-of-Care | 4 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death (Withdrawal of Life Support) | General disorders | Standard-of-Care Plus Precedex | 1 | 44 | 1 |
| serious | Death (Withdrawal of Life Support) | General disorders | Standard-of-Care | 0 | 40 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard-of-Care Plus Precedex | ||
| Total, all-cause mortality | Standard-of-Care | ||
| Total, other adverse events | Standard-of-Care Plus Precedex | 0 | 44 |
| Total, other adverse events | Standard-of-Care | 0 | 40 |
| Total, serious adverse events | Standard-of-Care Plus Precedex | 1 | 44 |
| Total, serious adverse events | Standard-of-Care | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24506248 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Standard-of-Care Plus Precedex vs Standard-of-Care: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01169467
GET https://conductscience.org/api/trials/v1/NCT01169467/registered