Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

This study has been completed.
Information provided by (Responsible Party):
John Bebawy, Northwestern University
ClinicalTrials.gov Identifier:
First received: October 8, 2009
Last updated: October 28, 2015
Last verified: October 2015
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 Intervention Phase
Brain Neoplasms
Intracranial Aneurysm
Drug: Insulin
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • performance of each of glucose sampling and insulin protocols for achieving euglycemia [ Time Frame: duration of operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hypoglycemia [ Time Frame: duration of operation ] [ Designated as safety issue: Yes ]
  • time required to reach euglycemia [ Time Frame: durarion of operation ] [ Designated as safety issue: No ]
  • relationship of BMI and performance of protocols [ Time Frame: duration of operation ] [ Designated as safety issue: No ]
  • relationship of serum biomarkers of insulin resistance and performance of protocols [ Time Frame: duration of operation ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information


Responsible Party: John Bebawy, Assistant Professor in Anesthesiology and Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT00993057     History of Changes
Other Study ID Numbers: STU00009023
Study First Received: October 8, 2009
Last Updated: October 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:

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

ClinicalTrials.gov processed this record on November 25, 2015