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Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01565590
Recruitment Status : Terminated (Slow enrollment along with new competing studies, investigators decided to stop study)
First Posted : March 28, 2012
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
Shaun Keegan, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Drug: Dexmedetomidine Drug: propofol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
Study Start Date : February 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Propofol Drug: propofol
5-80 mcg/kg/min

Experimental: Dexmedetomidine Drug: Dexmedetomidine
0.2-1.5 mcg/kg/hr

Primary Outcome Measures :
  1. Changes between serum and CSF cytokines over 48 hours [ Time Frame: 0, 24 and 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).

Secondary Outcome Measures :
  1. Sedative and analgesic medication requirements [ Time Frame: 2 weeks ]
    Sedation requirements between the two groups will be assessed by comparing total daily dose and average daily fentanyl doses in the 24 hours following surgery. The total number of patients requiring propofol rescue in the dexmedetomidine group and the total daily dose and average daily dose of the propofol used in the dexmedetomidine group will be recorded.

  2. Sedation scores (RASS and CAM-ICU) [ Time Frame: 2 weeks ]
  3. ICU length of stay [ Time Frame: 2 weeks ]
  4. Hospital length of stay [ Time Frame: 2 weeks ]
  5. Glasgow Outcome Scores Extended (GOSE) at discharge [ Time Frame: 2 weeks ]
  6. Incidence of delayed cerebral ischemia (DCI) [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01565590

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United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
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Responsible Party: Shaun Keegan, Clinical Pharmacy Specialist, Critical Care, University of Cincinnati Identifier: NCT01565590    
Other Study ID Numbers: 11-11-22-01
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Keywords provided by Shaun Keegan, University of Cincinnati:
aneurysmal subarachnoid hemorrhage
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action