Comparative Trial Between 3 Types of Insulin Infusion Protocols
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|ClinicalTrials.gov Identifier: NCT00582309|
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : January 25, 2010
Last Update Posted : June 23, 2015
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Increasing evidence from observational studies in hospitalized patients with and without diabetes indicates that hyperglycemia is a predictor of poor outcome. Over the short-term, hyperglycemia can adversely affects fluid balance (through glycosuria and dehydration), impairs immunologic response to infection, and promotes inflammation and endothelial dysfunction. Blood glucose control with intensive insulin therapy in patients with acute critical illness reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality .
- Hypotheses: we hypothesize that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol (Glucommander) will facilitate a smoother glycemic control with a lower rate of hypoglycemic events than treatment following a standard insulin infusion algorithm or a simple calculated infusion protocol in critically ill patients in the medical and surgical ICU.
|Condition or disease||Intervention/treatment||Phase|
|Hyperglycemia||Procedure: Glucommander-Guided Intravenous Insulin Infusion Procedure: Standard Intravenous Insulin Infusion Procedure: Simple Calculated Intravenous Insulin Infusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Trial Between Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm Versus a Simple Calculated Infusion Protocol in Medical and Surgical ICU|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: Glucommander
Glucommander-Guided Intravenous Insulin Infusion
Procedure: Glucommander-Guided Intravenous Insulin Infusion
Glucommander-Guided Intravenous Insulin Infusion.
Other Name: Computer controlled Algorithm for insulin administration
Active Comparator: Standard
Standard Intravenous Insulin Infusion Algorithm consists of four levels (Algorithm 1-3 and a doubling of the insulin rate). Most patients begin in algorithm 1, where the insulin rate varies from 0.2 units per hour for BG in the range 70-109 mg/dl up to 6 units/hr for BG > 360 mg/dl. If algorithm 1 fails to bring the patient's BG into target range in 2 hrs, then the patient is moved up to algorithm 2, where the insulin rate varies from 0.5 to 12 units/hr; and if that fails, the patient moved up to algorithm 3, where insulin rate varies from 1 to 16 units/hr depending on the latest BG. Algorithm failure is a blood glucose outside the target range for 2 hrs, and the blood glucose does not decrease by at least 60 mg/dl within 1 hr. If algorithm 3 fails, the insulin rate is doubled.
Procedure: Standard Intravenous Insulin Infusion
Standard Intravenous Insulin Infusion Standard Intravenous Insulin Infusion in the ICU setting Prepare IV Insulin Drip: 250 units of glulisine (Apidra®) insulin with 250 ml NS (1.0 unit/ml). Piggyback insulin drip into IV fluids.
Algorithm 1: Start here for most patients. Algorithm 2: For patients not controlled with Algorithm 1, or receiving glucocorticoids, or patient with diabetes receiving >80 units/day of insulin as an outpatient.
Algorithm 3: For patients not controlled on Algorithm 2.No Patients Start Here.
Other Name: Algorithm controlled insulin administration
Active Comparator: Simple
Simple Calculated Intravenous Insulin Infusion consists of an initial insulin infusion rate varying from 0.5 units per hour for BG in the target range 80-120 mg/dl up to 8 units/hour for BG > 400 mg/dl. After the initial insulin rate and if BG is still > 120 mg/dl, then the insulin rate is increased by 1-2 units every 1 hour until BG is in the target range. If BG is still >120 mg/dl in 2 hours, then the insulin rate is doubled.
Procedure: Simple Calculated Intravenous Insulin Infusion
If the patient was on insulin prior to this admission, 1/2 of the total insulin dose divided by 24 will be the initial insulin infusion rate. The amount of insulin given will be dependant upon blood sugar levels ( BG levels 80-120= 0.5 units/hr, 121-160=1.0 units/hr, 161-200= 2.0 units/hr, 201-240= 3.0 units/hr, 241-280= 4.0 units/hr, 281-320= 5.0 units/hr, 321-360=6.0 units, 361-400= 7.0 units, greater than 400= 8.0 units.
Other Name: Simple sliding scale for insulin administration
- Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group. [ Time Frame: 24 hours ]The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG < 120, and maintaining the target range thereafter.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients who are admitted to Medical or Surgical ICU.
- History of diabetes mellitus
- Newly diagnosed hyperglycemia (defined as a blood glucose greater than 140 mg/dl on ≥ 2 occasions)
- Subjects must have an admission blood glucose < 500 mg/dL, without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
- Non-Diabetic patients
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Patients with known HIV
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl).
- Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast feeding at time of enrollment into the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582309
|United States, Illinois|
|St. James Hospital and Health Centers|
|Chicago Heights, Illinois, United States, 60411|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|University of New Mexico Hospital|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Gary Iwamoto, M.D.||University of New Mexico|
|Responsible Party:||Gary Iwamoto, Principal Investigator, University of New Mexico|
|Other Study ID Numbers:||
|First Posted:||December 28, 2007 Key Record Dates|
|Results First Posted:||January 25, 2010|
|Last Update Posted:||June 23, 2015|
|Last Verified:||May 2015|
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