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

NCT ID: NCT01565590

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

5-80 mcg/kg/min

Dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

0.2-1.5 mcg/kg/hr

Interventions

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Dexmedetomidine

0.2-1.5 mcg/kg/hr

Intervention Type DRUG

propofol

5-80 mcg/kg/min

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Shaun Keegan

Clinical Pharmacy Specialist, Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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11-11-22-01

Identifier Type: -

Identifier Source: org_study_id

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