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Comparative Trial Between 3 Types of Insulin Infusion Protocols
This study is currently recruiting participants.
Verified by University of New Mexico, October 2008
First Received: December 19, 2007   Last Updated: October 1, 2008   History of Changes
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 [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.

  Show Detailed Description

  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

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 November 25, 2009



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