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

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
propofol
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring aneurysmal subarachnoid hemorrhage, dexmedetomidine, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol

Dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sedative and analgesic medication requirements
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)
ICU length of stay
Hospital length of stay
Glasgow Outcome Scores Extended (GOSE) at discharge
Incidence of delayed cerebral ischemia (DCI)

Full Information

First Posted
March 23, 2012
Last Updated
January 30, 2018
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01565590
Brief Title
Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
Official Title
Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment along with new competing studies, investigators decided to stop study
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal
Keywords
aneurysmal subarachnoid hemorrhage, dexmedetomidine, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Title
Dexmedetomidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
0.2-1.5 mcg/kg/hr
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
5-80 mcg/kg/min
Primary Outcome Measure Information:
Title
Changes between serum and CSF cytokines over 48 hours
Description
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).
Time Frame
0, 24 and 48 hours
Secondary Outcome Measure Information:
Title
Sedative and analgesic medication requirements
Description
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.
Time Frame
2 weeks
Title
Sedation scores (RASS and CAM-ICU)
Time Frame
2 weeks
Title
ICU length of stay
Time Frame
2 weeks
Title
Hospital length of stay
Time Frame
2 weeks
Title
Glasgow Outcome Scores Extended (GOSE) at discharge
Time Frame
2 weeks
Title
Incidence of delayed cerebral ischemia (DCI)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

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

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