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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Shaun Keegan, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01565590
First received: March 23, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Subarachnoid Hemorrhage, Aneurysmal
Drug: Dexmedetomidine
Drug: propofol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Changes between serum and CSF cytokines over 48 hours [ Time Frame: 0, 24 and 48 hours ] [ Designated as safety issue: No ]
    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:
  • Sedative and analgesic medication requirements [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Glasgow Outcome Scores Extended (GOSE) at discharge [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Incidence of delayed cerebral ischemia (DCI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol Drug: propofol
5-80 mcg/kg/min
Experimental: Dexmedetomidine Drug: Dexmedetomidine
0.2-1.5 mcg/kg/hr

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565590

Locations
United States, Ohio
University Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Shaun P Keegan, Pharm.D.       shaun.keegan@uchealth.com   
Contact: Brittany Woolf, Pharm.D.       brittany.woolf@uchealth.com   
Sponsors and Collaborators
University of Cincinnati
  More Information

No publications provided

Responsible Party: Shaun Keegan, Clinical Pharmacy Specialist, Critical Care, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01565590     History of Changes
Other Study ID Numbers: 11-11-22-01
Study First Received: March 23, 2012
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
aneurysmal subarachnoid hemorrhage
dexmedetomidine
cytokines

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Dexmedetomidine
Propofol
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on October 20, 2014