Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia - Full Text View

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:

MedlinePlus related topics: Diabetes Medicines Hypoglycemia

Drug Information available for: Insulin human Dextrose

U.S. FDA Resources

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

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

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:

Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. Review.

Lukins MB, Manninen PH. Hyperglycemia in patients administered dexamethasone for craniotomy. Anesth Analg. 2005 Apr;100(4):1129-33.

Lindsberg PJ, Roine RO. Hyperglycemia in acute stroke. Stroke. 2004 Feb;35(2):363-4. No abstract available.

Pasternak JJ, McGregor DG, Schroeder DR, Lanier WL, Shi Q, Hindman BJ, Clarke WR, Torner JC, Weeks JB, Todd MM; IHAST Investigators. Hyperglycemia in patients undergoing cerebral aneurysm surgery: its association with long-term gross neurologic and neuropsychological function. Mayo Clin Proc. 2008 Apr;83(4):406-17.

Carvalho G, Moore A, Qizilbash B, Lachapelle K, Schricker T. Maintenance of normoglycemia during cardiac surgery. Anesth Analg. 2004 Aug;99(2):319-24, table of contents.

Geroldi D, Falcone C, Emanuele E. Soluble receptor for advanced glycation end products: from disease marker to potential therapeutic target. Curr Med Chem. 2006;13(17):1971-8. Review.

Meng YX, Ford ES, Li C, Quarshie A, Al-Mahmoud AM, Giles W, Gibbons GH, Strayhorn G. Association of C-reactive protein with surrogate measures of insulin resistance among nondiabetic US from National Health and Nutrition Examination Survey 1999-2002. Clin Chem. 2007 Dec;53(12):2152-9. Epub 2007 Oct 19.

Olufadi R, Byrne CD. Clinical and laboratory diagnosis of the metabolic syndrome. J Clin Pathol. 2008 Jun;61(6):697-706. Review.

Yamauchi T, Kamon J, Waki H, Terauchi Y, Kubota N, Hara K, Mori Y, Ide T, Murakami K, Tsuboyama-Kasaoka N, Ezaki O, Akanuma Y, Gavrilova O, Vinson C, Reitman ML, Kagechika H, Shudo K, Yoda M, Nakano Y, Tobe K, Nagai R, Kimura S, Tomita M, Froguel P, Kadowaki T. The fat-derived hormone adiponectin reverses insulin resistance associated with both lipoatrophy and obesity. Nat Med. 2001 Aug;7(8):941-6.

Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8.

Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94.

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013