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

January 30, 2018 updated by: Shaun Keegan, University of Cincinnati
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Propofol
Drug: propofol
5-80 mcg/kg/min
EXPERIMENTAL: Dexmedetomidine
Drug: Dexmedetomidine
0.2-1.5 mcg/kg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes between serum and CSF cytokines over 48 hours
Time Frame: 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).
0, 24 and 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedative and analgesic medication requirements
Time Frame: 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.
2 weeks
Sedation scores (RASS and CAM-ICU)
Time Frame: 2 weeks
2 weeks
ICU length of stay
Time Frame: 2 weeks
2 weeks
Hospital length of stay
Time Frame: 2 weeks
2 weeks
Glasgow Outcome Scores Extended (GOSE) at discharge
Time Frame: 2 weeks
2 weeks
Incidence of delayed cerebral ischemia (DCI)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-11-22-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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