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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00615381 |
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Date of registration:
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21/01/2008 |
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Primary sponsor: |
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Public title:
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Supraphysiologic Insulin to Improve Outcomes After Surgical Treatment of Unruptured Cerebral Aneurysms
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Scientific title:
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Clinical Trial of Euglycemia Maintenance With Supraphysiologic Insulin vs Conventional Intensive Insulin Therapy to Improve Outcomes (Neurologic, Neuropsychiatric, and Biomarkers) After Surgical Treatment of Unruptured Cerebral Aneurysms |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00615381 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Dhanesh K. Gupta, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University Feinberg School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Unruptured intracranial aneurysm
Exclusion Criteria:
- Diabetes
- Pregnancy
- Age less than 18 years
- Inability to undergo preoperative neuropsychiatric and neurologic functional testing
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intracranial Aneurysm
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Intervention(s)
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Drug: Novolin R (Human Recombinant Insulin)
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Primary Outcome(s)
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Neurologic Outcome--"poor" vs. "good." A "poor" outcome is assigned if the patient who arrived independently from home is discharged to a nursing home or rehabilitation hospital or dies.
[Time Frame: Discharge from hospital after surgery]
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Secondary Outcome(s)
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Amount of time blood glucose concentration is outside the target glucose concentration range (80-120 mg/dL)
[Time Frame: Perioperative Period (Induction of anesthesia + 24 hrs)]
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Biomarkers of the Perioperative Inflammatory Response
[Time Frame: Perioperative Period (Induction of anesthesia + 48 hrs)]
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Neurologic Status (Glasgow Outcome Scale <=4; Modified Rankin Disability Scale >=2, NIH Stroke Scale <=10)
[Time Frame: Postoperative day 7, 90+/- 14 days, and 365+/-30 days]
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Neuropsychiatric outcomes
[Time Frame: Postoperative day 7, 90+/- 14 days, and 365+/-30 days]
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Secondary ID(s)
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DKG 2498-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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