Study Stopped
Slow enrollment along with new competing studies, investigators decided to stop study
Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
1 other identifier
interventional
4
1 country
1
Brief Summary
The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 1, 2018
January 1, 2018
3.4 years
March 23, 2012
January 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes between serum and CSF cytokines over 48 hours
Measure the baseline level (at enrollment) of inflammatory markers tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), glial fibrially acidic protein (GFAP), and malondialdehyde (MDA) as measured in both serum and cerebrospinal fluid (CSF) in 10 patients with aneurysmal subarachnoid hemorrhage (aSAH).
0, 24 and 48 hours
Secondary Outcomes (6)
Sedative and analgesic medication requirements
2 weeks
Sedation scores (RASS and CAM-ICU)
2 weeks
ICU length of stay
2 weeks
Hospital length of stay
2 weeks
Glasgow Outcome Scores Extended (GOSE) at discharge
2 weeks
- +1 more secondary outcomes
Study Arms (2)
Propofol
ACTIVE COMPARATORDexmedetomidine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Aneurysmal subarachnoid hemorrhage
- World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
- Surgical intervention with clip or coil
- Placement of cerebrospinal fluid drain (lumbar or ventricular)
- Mechanically ventilated at start of infusion
You may not qualify if:
- Hemodynamic instability (SBP \< 100, HR \<60, or on continuous infusion of catecholamines) at screening
- Heart failure class III or IV (New York Heart Association)
- Renal failure (RIFLE classification - see table below)
- Liver failure (serum protein \< 3 g/dL and total bilirubin \> 5 mg/dL)
- Known or suspected brain death
- Pregnancy
- Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery
- Allergy to dexmedetomidine
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Cincinnati, Ohio, 45219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacy Specialist, Critical Care
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 28, 2012
Study Start
February 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
February 1, 2018
Record last verified: 2018-01