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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01565590
• Other study ID #: 11-11-22-01
• Status: Terminated
• Phase: Phase 3
• First received: March 23, 2012
• Last updated: January 30, 2018
• Start date: February 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

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

Locations

Country	Name	City	State
United States	University Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes between serum and CSF cytokines over 48 hours	Measure the baseline level (at enrollment) of inflammatory markers tumor necrosis factor-alpha (TNF-a), 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).	0, 24 and 48 hours
Secondary	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.	2 weeks
Secondary	Sedation scores (RASS and CAM-ICU)		2 weeks
Secondary	ICU length of stay		2 weeks
Secondary	Hospital length of stay		2 weeks
Secondary	Glasgow Outcome Scores Extended (GOSE) at discharge		2 weeks
Secondary	Incidence of delayed cerebral ischemia (DCI)		2 weeks