Supraphysiologic Insulin to Improve Outcomes After Surgical Treatment of Unruptured Cerebral Aneurysms

This study has been withdrawn prior to enrollment.
(Study was not initiated and has been withdrawn due to lack of appropriate cases)
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00615381
First received: January 21, 2008
Last updated: January 20, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention
Intracranial Aneurysm
Drug: Novolin R (Human Recombinant Insulin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychiatric outcomes [ Time Frame: Postoperative day 7, 90+/- 14 days, and 365+/-30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Biomarkers of the Perioperative Inflammatory Response [ Time Frame: Perioperative Period (Induction of anesthesia + 48 hrs) ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal
Maintenance of intraoperative euglycemia (blood glucose 80--110 mg/dL) using normal intensive insulin infusion rates (0-10 U/hr).
Drug: Novolin R (Human Recombinant Insulin)
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)
Experimental: Supraphysiologic
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: Novolin R (Human Recombinant Insulin)
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unruptured intracranial aneurysm

Exclusion Criteria:

  • Diabetes
  • Pregnancy
  • Age less than 18 years
  • Inability to undergo preoperative neuropsychiatric and neurologic functional testing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615381

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Dhanesh K. Gupta, M.D. Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Dhanesh K. Gupta, M.D., Assistant Professor of Anesthesiology & Neurological Surgery, Northwestern University Feinberg School of Medicine
ClinicalTrials.gov Identifier: NCT00615381     History of Changes
Other Study ID Numbers: DKG 2498-002
Study First Received: January 21, 2008
Last Updated: January 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Intracranial Aneurysm, Unruptured
Craniotomy
Insulin
Neuropsychology

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014