Comparative Trial Between 3 Types of Insulin Infusion Protocols - Full Text View

Sponsor:	University of New Mexico
Collaborator:	Sanofi-Aventis
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00582309

Purpose

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	Intervention
Hyperglycemia	Procedure: Glucommander-Guided Intravenous Insulin Infusion Procedure: Standard Intravenous Insulin Infusion Procedure: Simple Calculated Intravenous Insulin Infusion

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin Insulin beef

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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.

Enrollment:	151
Study Start Date:	August 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Glucommander Glucommander-Guided Intravenous Insulin Infusion	Procedure: Glucommander-Guided Intravenous Insulin Infusion Glucommander-Guided Intravenous Insulin Infusion. Prepare IV Insulin Drip: 250 units of glulisine (Apidra®) insulin with 250 ml NS (1.0 unit/ml). Piggyback insulin drip into IV fluids. During the infusion, enter glucose levels into the Glucommander and follow recommendations regarding infusion rate and time to measure next blood glucose levels. 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

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582309

Locations

United States, Illinois
St. James Hospital and Health Centers
Chicago Heights, Illinois, United States, 60411
United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87131
Presbyterian Hospital
Albuquerque, New Mexico, United States, 87106

Sponsors and Collaborators

University of New Mexico

Sanofi-Aventis

Investigators

Principal Investigator:

Gary Iwamoto, M.D.

University of New Mexico

More Information

No publications provided

Responsible Party:	Gary Iwamoto, MD, University of New Mexico
ClinicalTrials.gov Identifier:	NCT00582309 History of Changes
Other Study ID Numbers:	HRRC 06-288
Study First Received:	December 19, 2007
Results First Received:	September 12, 2009
Last Updated:	August 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Glycemic Control
Intravenous Infusion
Standard Insulin infusion algorithm
Infusion
Critically Ill

Additional relevant MeSH terms:

Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012