Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00993057
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : June 15, 2016
Information provided by (Responsible Party):
John Bebawy, Northwestern University

Brief Summary:
What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Intracranial Aneurysm Drug: Insulin Early Phase 1

Detailed Description:

Intraoperative blood glucose levels will be maintained in the target range of 90—110 mg/dL (euglycemia) using the protocol. The target serum glucose ranges chosen (90-110 mg/dL) was chosen to specifically target those levels associated with the best outcome in cerebral aneurysm surgery (serum glucose < 108 mg/dL) and aggressively avoid those levels associated with cognitive dysfunction (serum glucose < 128 mg/dL) and gross neurologic deficits (serum glucose < 152 mg/dL). Because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies.

Each patient will be randomly assigned to one of two frequency of intervention groups—Group 30 will have the insulin dose adjusted every 30 minutes and Group 60 will have the insulin dose adjusted every 60 minutes. Blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective Intraoperative Insulin & Glucose data sheet (Appendix 2 and 3 for Group 30 and Group 60, respectively).

Regardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group). The interval data (15 minutes for the 30 min group and 15, 30, and 45 minutes for the 1 hour group) will be utilized to determine the pharmacodynamic effects of insulin (dose-response relationship). Interventions will only be performed at the assigned interval (30 vs 60 min) unless the glucose level is < 70 mg/dL, at which time the patient will receive 25 mL of 50% Dextrose solution. For these rescued patients, the protocol will be continued as scheduled.

On the day of surgery, after confirming entry into the study (i.e., confirmation of research consent), each patient will be randomly assigned to a specific protocol—q 30 minutes glucose measurements and intervention vs. q 60 minutes glucose measurements and intervention.Randomization will be performed in blocks of 10 using a computer generated random number assignment (odd numbers = q 30 minutes and even numbers = q 60 minutes)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Two Glucose Sampling Frequencies for an Intensive Insulin Protocol During Craniotomy in Non-Diabetic Patients—How Efficiently and Safely Can We Maintain Target Glucose Levels
Study Start Date : October 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Q1 hour protocol
change of insulin infusion every hour
Drug: Insulin
Adjustable insulin infusion scale with loading doses
Other Name: Humulin

Active Comparator: Q30min protocol
change of insulin infusion every 30 minutes
Drug: Insulin
Adjustable insulin infusion scale with loading doses
Other Name: Humulin

Primary Outcome Measures :
  1. performance of each of glucose sampling and insulin protocols for achieving euglycemia [ Time Frame: duration of operation ]

Secondary Outcome Measures :
  1. hypoglycemia [ Time Frame: duration of operation ]
  2. time required to reach euglycemia [ Time Frame: durarion of operation ]
  3. relationship of BMI and performance of protocols [ Time Frame: duration of operation ]
  4. relationship of serum biomarkers of insulin resistance and performance of protocols [ Time Frame: duration of operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All English speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms.

Exclusion Criteria:

  • Patients under 18 years of age, patients who are pregnant, patients with diabetes, BMI > 33 kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00993057

United States, Illinois
Dhanesh Gupta
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Dhanesh Gupta, MD Northwestern University Feinberg School of Medicine


Responsible Party: John Bebawy, Assistant Professor in Anesthesiology and Neurological Surgery, Northwestern University Identifier: NCT00993057     History of Changes
Other Study ID Numbers: STU00009023
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Bebawy, Northwestern University:

Additional relevant MeSH terms:
Intracranial Aneurysm
Brain Neoplasms
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs