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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.
Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-of-Care plus Precedex | Active Comparator | Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment. |
|
| Standard-of-Care | Placebo Comparator | Subjects who are treated with the standard of care sedation regiment only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-Care plus Dexmedetomidine | Drug | Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variability of Intracranial Pressure (ICP) | 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 | Baseline to 24 hours |
| Change in Pressure Reactivity Index (PRx) | 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. | Baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury | 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. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Dombrowski, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24506248 | Background | Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7. |
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89 subject signed consent, 5 subjects screen failed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard-of-Care | Subjects who are treated with the standard of care sedation regiment only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Standard-of-Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Variability of Intracranial Pressure (ICP) | 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 | Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis. | Posted | Mean | Standard Error | mmHg | Baseline to 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (Withdrawal of Life Support) | General disorders | Family decided to withdraw support on the patient during study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keith Dombrowski | Duke University Medical Center | (919) | keith.dombrowski@dm.duke.edu |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard-of-Care | Other | Subjects who are treated with the standard of care sedation regiment only. |
|
| Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury | 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. | Baseline to 24 hours |
| Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury | 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. | Baseline to 24 hours |
Subjects who are treated with the standard of care sedation regiment only.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Subjects who are treated with the standard of care sedation regiment only.
|
|
| Primary | Change in Pressure Reactivity Index (PRx) | 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. | Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis. | Posted | Mean | Standard Error | Pressure Reactivity Index | Baseline to 24 hours |
|
|
|
|
| Secondary | Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury | 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. | Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis. | Posted | Mean | Standard Error | mg/ml | 24 hours |
|
|
|
| Secondary | Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury | 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. | Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis. | Posted | Mean | Standard Error | mmHg | Baseline to 24 hours |
|
|
|
| Secondary | Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury | 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. | Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis. | Posted | Mean | Standard Error | mmHg | Baseline to 24 hours |
|
|
|
| 1 |
| 44 |
| 0 |
| 44 |
| EG001 | Standard-of-Care | Subjects who are treated with the standard of care sedation regiment only. | 0 | 40 | 0 | 40 |
|
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| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |