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

Sponsors and Collaborators:	University of New Mexico 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 [1-5]. 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 [6-11]. Blood glucose control with intensive insulin therapy in patients with acute critical illness reduces the risk of multiorgan failure and systemic infections [12-14], and decreases short- and long-term mortality [12, 15].

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	Other: Glucommander-Guided Intravenous Insulin Infusion (glulisine (Apidra®) insulin ) Other: Standard Intravenous Insulin Infusion Other: Simple Calculated Intravenous Insulin Infusion

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment, Efficacy Study
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: Surgery

Drug Information available for: Insulin Insulin glulisine

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose concentration between treatment groups. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Differences between treatment groups in: number of hypoglycemic events (blood glucose < 60 mg/dl and < 40 mg/dl), length of ICU stay and length of hospital stay, and number of hyperglycemic episodes (blood glucose > 180 mg/dl). [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Glucommander-Guided Intravenous Insulin Infusion (n= 50)	Other: Glucommander-Guided Intravenous Insulin Infusion (glulisine (Apidra®) insulin ) 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.
2: Active Comparator Standard Intravenous Insulin Infusion Algorithm (n=50)	Other: 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.
3: Active Comparator Simple Calculated Intravenous Insulin Infusion (n=50)	Other: 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.

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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

Contacts

Contact: Zellisha Quam, BS

505-272-2836

ZQuam@salud.unm.edu

Locations

United States, Illinois
St. James Hospital and Health Centers	Recruiting
Chicago Heights, Illinois, United States, 60411
Contact: Arcot Dwarakanathan, M.D. 708-709-2010 arcotd@yahoo.com
Principal Investigator: Arcot Dwarakanthan, M.D.
United States, New Mexico
University of New Mexico Hospital	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Stephanie Sanderson, RN 505-272-2607 ssanderson@salud.unm.edu
Contact: Vivian Prinz, RN 505-272-2607 vprinz@salud.unm.edu
Principal Investigator: Gary Iwamoto, M.D.
Presbyterian Hospital	Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Robert Galagan, M.D. 505-291-6400
Principal Investigator: Robert Galagan, M.D.

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:	University of New Mexico ( Gary Iwamoto, MD )
Study ID Numbers:	HRRC 06-288
Study First Received:	December 19, 2007
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00582309 History of Changes
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

Study placed in the following topic categories:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Hyperglycemia
Critical Illness

Glucose Metabolism Disorders
Glucocorticoids
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Physiological Effects of Drugs

Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 06, 2009