Overview
Supraphysiologic Insulin to Improve Outcomes After Surgical Treatment of Unruptured Cerebral Aneurysms
Status:
Withdrawn
Withdrawn
Trial end date:
2010-01-01
2010-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
We hypothesize that in patients undergoing surgical treatment of unruptured intracranial aneurysms, the increase in blood sugar as a result of surgical stress is detrimental to outcome, as measured by blood levels of proteins associated with systemic inflammation and 7 day, 90 day, and 1 year postoperative neurologic and neuropsychiatric outcomes. Because insulin itself is an anti-inflammatory agent, we anticipate that normalizing blood sugar levels with insulin doses higher than normally produced by the body (i.e., "supraphysiologic" insulin doses) will have a greater benefit on these outcomes than equally normalizing blood sugar levels using normal insulin doses. Based on the results of this study, we will be able to determine if a more laborious strategy to normalize blood sugar levels (i.e., "supraphysiologic" insulin therapy) offers any additional benefits to normal insulin dosing strategies. In addition, we will obtain a robust assessment of postoperative neuropsychiatric and neurologic outcomes of surgically repaired unruptured intracranial aneurysms that will serve as the basis for future studies to decrease morbidity of these patientsPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Northwestern UniversityTreatments:
Insulin
Insulin, Globin Zinc
Criteria
Inclusion Criteria:- Unruptured intracranial aneurysm
Exclusion Criteria:
- Diabetes
- Pregnancy
- Age less than 18 years
- Inability to undergo preoperative neuropsychiatric and neurologic functional testing