NCT00615381

Brief 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 patients

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

January 21, 2008

Last Update Submit

April 21, 2015

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysm, UnrupturedCraniotomyInsulinNeuropsychology

Outcome Measures

Primary Outcomes (1)

  • 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.

    Discharge from hospital after surgery

Secondary Outcomes (4)

  • Neuropsychiatric outcomes

    Postoperative day 7, 90+/- 14 days, and 365+/-30 days

  • Neurologic Status (Glasgow Outcome Scale <=4; Modified Rankin Disability Scale >=2, NIH Stroke Scale <=10)

    Postoperative day 7, 90+/- 14 days, and 365+/-30 days

  • Amount of time blood glucose concentration is outside the target glucose concentration range (80-120 mg/dL)

    Perioperative Period (Induction of anesthesia + 24 hrs)

  • Biomarkers of the Perioperative Inflammatory Response

    Perioperative Period (Induction of anesthesia + 48 hrs)

Study Arms (2)

Normal insulin

ACTIVE COMPARATOR

Maintenance of intraoperative euglycemia (blood glucose 80--110 mg/dL) using normal intensive insulin infusion rates (0-10 U/hr).

Drug: Insulin

Supraphysiologic insulin

EXPERIMENTAL

Maintenance of intraoperative euglycemia (blood glucose 80--110 mg/dL) using supraphysiologic insulin infusion doses (0.3 U/kg/hr) and exogenous dextrose to provide stable blood glucose levels .

Drug: Insulin

Interventions

InsulinDRUG

insulin infusion (0-10 U/hr) vs. 0.3 U/kg/hr and boluses (0-8 U) adjusted every 15 minutes during the intraoperative period to maintain intraoperative euglycemia (blood glucose levels 80-120 mg/dL)

Also known as: Novolin R (Human Recombinant Insulin)
Normal insulinSupraphysiologic insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unruptured intracranial aneurysm

You may not qualify if:

  • Diabetes
  • Pregnancy
  • Age less than 18 years
  • Inability to undergo preoperative neuropsychiatric and neurologic functional testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Intracranial AneurysmInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dhanesh K. Gupta, M.D.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology & Neurological Surgery

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 14, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

US(1)