Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

December 11, 2019 updated by: John Bebawy, Northwestern University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Dhanesh Gupta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Q1 hour protocol
change of insulin infusion every hour
Drug: Insulin
Adjustable insulin infusion scale with loading doses
Other Names:
  • Humulin
Active Comparator: Q30min protocol
change of insulin infusion every 30 minutes
Drug: Insulin
Adjustable insulin infusion scale with loading doses
Other Names:
  • Humulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
duration of operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemia
Time Frame: duration of operation
Hypoglycemia occurring the operation
duration of operation
time required to reach euglycemia
Time Frame: durarion of operation
Elapsed time required to reach euglycemia during the operation
durarion of operation
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
duration of operation
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
duration of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Dhanesh Gupta, MD, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00009023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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