Clinical trial NCT00993057: Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Brain Neoplasms
Intracranial Aneurysm
Keywords: Euglycemia
craniotomy
neurosurgery
hypoglycemia
insulin
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: performance of each of glucose sampling and insulin protocols for achieving euglycemia
timeFrame: duration of operation
Secondary outcomes:
measure: hypoglycemia
timeFrame: duration of operation
measure: time required to reach euglycemia
timeFrame: durarion of operation
measure: relationship of BMI and performance of protocols
timeFrame: duration of operation
measure: relationship of serum biomarkers of insulin resistance and performance of protocols
timeFrame: duration of operation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Dhanesh Gupta
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Dhanesh Gupta, MD
role: PRINCIPAL_INVESTIGATOR
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