Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/23/2018 |
| Start Date: | October 2009 |
| End Date: | August 2012 |
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
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.
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.
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)
(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)
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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