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

Phase 3

Terminated

• Conditions: Subarachnoid Hemorrhage, Aneurysmal
• Interventions: Drug: propofol; Drug: Dexmedetomidine

• Registration Number: NCT01565590
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	propofol	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Changes between serum and CSF cytokines over 48 hours	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

Name	Time	Method
Hospital length of stay	2 weeks
Incidence of delayed cerebral ischemia (DCI)	2 weeks
Glasgow Outcome Scores Extended (GOSE) at discharge	2 weeks
Sedative and analgesic medication requirements	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)	2 weeks
ICU length of stay	2 weeks

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Cincinnati, Ohio, United States