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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2015

Interventions

  • Drug: Dexmedetomidine
    • 0.2-1.5 mcg/kg/hr
  • Drug: propofol
    • 5-80 mcg/kg/min

Arms, Groups and Cohorts

  • Active Comparator: Propofol
  • Experimental: Dexmedetomidine

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cincinnati
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shaun Keegan, Clinical Pharmacy Specialist, Critical Care – University of Cincinnati

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