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OpenTrials
Completed

NCT Number: NCT00993057

Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

Adjustable insulin infusion scale with loading doses

Other names: Humulin

Primary outcomes

  1. performance of each of glucose sampling and insulin protocols for achieving euglycemia

    Time frame: duration of operation

    performance of each of glucose sampling and insulin protocols for achieving euglycemia during the operation

Secondary outcomes

  1. hypoglycemia

    Time frame: duration of operation

    Hypoglycemia occurring the operation

  2. time required to reach euglycemia

    Time frame: durarion of operation

    Elapsed time required to reach euglycemia during the operation

  3. relationship of BMI and performance of protocols

    Time frame: duration of operation

    Evaluating the relationship of BMI (Body Mass Index) and the performance of protocols during the operation

  4. relationship of serum biomarkers of insulin resistance and performance of protocols

    Time frame: duration of operation

    Evaluating the relationship of serum biomarkers of insulin resistance and performance of protocols during the operation

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 9, 2009
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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