Comparative Trial Between 3 Types of Insulin Infusion Protocols

NCT00582309 | Completed Results

• 1 other identifier: HRRC 06-288
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hyperglycemia

Keywords

Glycemic Control; Intravenous Infusion; Standard Insulin infusion algorithm; Infusion; Critically Ill

Outcome Measures

Primary Outcomes (1)

• Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.

  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.

  24 hours

Study Arms (3)

Glucommander

ACTIVE COMPARATOR

Glucommander-Guided Intravenous Insulin Infusion

Procedure: Glucommander-Guided Intravenous Insulin Infusion

Standard

ACTIVE COMPARATOR

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

Simple

ACTIVE COMPARATOR

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

Interventions

Glucommander-Guided Intravenous Insulin Infusion PROCEDURE

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.

Also known as: Computer controlled Algorithm for insulin administration

Glucommander

Standard Intravenous Insulin Infusion PROCEDURE

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.

Also known as: Algorithm controlled insulin administration

Standard

Simple Calculated Intravenous Insulin Infusion PROCEDURE

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.

Also known as: Simple sliding scale for insulin administration

Simple

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• Sanofi: collaborator

Study Sites (3)

St. James Hospital and Health Centers

Chicago Heights, Illinois, 60411, United States

Location

Presbyterian Hospital

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Critical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of trial. Variable length of stay the first 48 hours was analyzed as the sample size decreased after that.

Results Point of Contact

• Title: Gary Iwamoto
• Organization: UNM

giwamoto@salud.unm.edu

505-272-4751

Study Officials

• Gary Iwamoto, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 23, 2015
• Results First Posted: January 25, 2010

Record last verified: 2015-05

Locations

US (3)