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Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dhanesh Gupta, Northwestern University
ClinicalTrials.gov Identifier:
NCT00993057
First received: October 8, 2009
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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
Craniotomy
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 Drug: Insulin
Q 15 min Glucose sampling. Q 30 or Q 60 min intervention depending on randomization Glc <70, 25mL D50 and hold initial insulin gtt until next intervention time or hold gtt until next intervention and decrease gtt 2U/hr Glc 70-79, 15mL D50 and hold initial insulin gtt until next intervention time or hold gtt until next intervention and decrease gtt 1U/hr Glc 80-89, hold initial insulin gtt or decrease insulin gtt 0.5 Glc 90-110, do not start infusion or no change in insulin gtt Glc 111-124, insulin 1U, start insulin gtt 0.5U or increase insulin gtt 0.5U/hr Glc 125-150, insulin 2U, start insulin gtt 1U/hr or increase insulin gtt 1U/hr Glc 151-180,insulin 4U, start insulin gtt 2U/hr or increase insulin gtt 2U/hr Glc 181-240, insulin 6U, start insulin gtt 3.5U/hr or increase insulin gtt 3U/hr Glc 241-300, insulin 8U, start insulin gtt 5U/hr or increase insulin gtt 4U/hr
Other Name: Humulin
Active Comparator: Q30min protocol Drug: Insulin
Q 15 min Glucose sampling. Q 30 or Q 60 min intervention depending on randomization Glc <70, 25mL D50 and hold initial insulin gtt until next intervention time or hold gtt until next intervention and decrease gtt 2U/hr Glc 70-79, 15mL D50 and hold initial insulin gtt until next intervention time or hold gtt until next intervention and decrease gtt 1U/hr Glc 80-89, hold initial insulin gtt or decrease insulin gtt 0.5 Glc 90-110, do not start infusion or no change in insulin gtt Glc 111-124, insulin 1U, start insulin gtt 0.5U or increase insulin gtt 0.5U/hr Glc 125-150, insulin 2U, start insulin gtt 1U/hr or increase insulin gtt 1U/hr Glc 151-180,insulin 4U, start insulin gtt 2U/hr or increase insulin gtt 2U/hr Glc 181-240, insulin 6U, start insulin gtt 3.5U/hr or increase insulin gtt 3U/hr Glc 241-300, insulin 8U, start insulin gtt 5U/hr or increase insulin gtt 4U/hr
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993057

Locations
United States, Illinois
Dhanesh Gupta
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Dhanesh Gupta, MD Northwestern University Feinberg School of Medicine
  More Information

Publications:

Responsible Party: Dhanesh Gupta, Associate Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT00993057     History of Changes
Other Study ID Numbers: STU00009023
Study First Received: October 8, 2009
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Euglycemia
craniotomy
neurosurgery
hypoglycemia
insulin

Additional relevant MeSH terms:
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014