PrePARE: Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Precedex-Propofol Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours. |
Drug: Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
|
| Active Comparator: Propofol- Precedex Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours. |
Drug: Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Lactate/Pyruvate (L/P)Ratio [1 hour]
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
-
Must require (be on) mechanical ventilation
-
must require (have in place) intracranial pressure (ICP) monitoring
-
must require (be receiving) continuous IV sedation
Exclusion Criteria:
-
Bleeding diathesis
-
Glasgow Coma Scale (GCS) < 5 with fixed pupils
-
Pregnant
-
elevated ICP that requires deep sedation
-
pulmonary instability
-
Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium
-
allergy to propofol or precedex
-
status epilepticus
-
current neuromuscular blockade
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Carmelo Graffagnino
- Hospira, now a wholly owned subsidiary of Pfizer
Investigators
- Principal Investigator: Carmelo Graffagnino, MD, Duke University
- Principal Investigator: DaiWai M Olson, PhD RN, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00002077
Study Results
Participant Flow
| Recruitment Details | Subjects approached if they had indwelling Licox catheters and were given sedation. |
|---|---|
| Pre-assignment Detail | Study started at onset of shift with 1 hour washout between crossover. One subject taken off sedation prior to enrollment because they were no longer eligible |
| Arm/Group Title | Precedex-Propofol | Propofol- Precedex |
|---|---|---|
| Arm/Group Description | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. | Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. |
| Period Title: Overall Study | ||
| STARTED | 5 | 3 |
| COMPLETED | 5 | 3 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Precedex-Propofol | Propofol- Precedex | Total |
|---|---|---|---|
| Arm/Group Description | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. | Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. | Total of all reporting groups |
| Overall Participants | 5 | 3 | 8 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
5
100%
|
2
66.7%
|
7
87.5%
|
| >=65 years |
0
0%
|
1
33.3%
|
1
12.5%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
33
(5.6)
|
55
(8.6)
|
41.5
(6.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
1
33.3%
|
1
12.5%
|
| Male |
5
100%
|
2
66.7%
|
7
87.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
5
100%
|
3
100%
|
8
100%
|
Outcome Measures
| Title | Lactate/Pyruvate (L/P)Ratio |
|---|---|
| Description | L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial. |
| Time Frame | 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Precedex-Propofol | Propofol- Precedex |
|---|---|---|
| Arm/Group Description | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. | Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. |
| Measure Participants | 5 | 3 |
| Mean (Standard Deviation) [ratio] |
103.1
(249.5)
|
33.8
(10.7)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Precedex-Propofol | Propofol- Precedex | ||
| Arm/Group Description | Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. | Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. | ||
All Cause Mortality |
||||
| Precedex-Propofol | Propofol- Precedex | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Precedex-Propofol | Propofol- Precedex | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/5 (20%) | 0/3 (0%) | ||
| Nervous system disorders | ||||
| Death to initial stroke | 1/5 (20%) | 1 | 0/3 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Precedex-Propofol | Propofol- Precedex | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/5 (40%) | 0/3 (0%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 |
| Cardiac disorders | ||||
| Bradycardia | 1/5 (20%) | 1 | 0/3 (0%) | 0 |
| Infections and infestations | ||||
| penumonia | 1/5 (20%) | 1 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolus | 1/5 (20%) | 1 | 0/3 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Carmelo Graffagnino |
|---|---|
| Organization | Duke University |
| Phone | 919/681-3751 |
| Carmelo.Graffagnino@duke.edu |
- Pro00002077