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Clinical Trials/NCT00582309
NCT00582309CompletedNot Applicable

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

University of New Mexico3 sites in 1 country151 target enrollmentStarted: August 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
151
Locations
3
Primary Endpoint
Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.

Study Overview

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.

Detailed Description

I. RESEARCH OBJECTIVES AND SPECIFIC AIMS

A. Introduction:

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 .

The use of intravenous insulin infusion is the preferred route of insulin administration for the management of diabetic subjects with diabetic ketoacidosis and nonketotic hyperosmolar state, intraoperative and postoperative care, the postoperative period following heart surgery and organ transplantation, acute myocardial infarction, stroke, and critical care illness. Some of these settings may be characterized by, or associated with, severe or rapidly changing insulin requirements, generalized patient edema, impaired perfusion of subcutaneous sites, requirement for pressor support, and/or use of total parenteral nutrition. In these settings, the intravenous route for insulin administration has been considered superior to the subcutaneous injection of split-mixed regimen of intermediate and regular insulin with respect to rapidity of effect in controlling hyperglycemia, overall ability to achieve glycemic control, and most importantly, preventing hypoglycemic episodes. Recently, several insulin infusion protocols have been reported in the literature . In general, orders to "titrate drip" are given to achieve a target blood glucose range using an established algorithm or by the application of mathematical rules by nursing staff. These algorithms and formulas, however, may be confusing and difficult to follow and may increase the risk of dosing errors. To facilitate patient care, insulin algorithms could be placed on a computer and used at the patient bedside to direct the nursing staff administering the intravenous insulin. The Glucommander is one such computer-derived insulin infusion protocol which has been used successfully in over 5,802 patients with diabetes between 1984 and 1998.

B. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Glucommander

Active Comparator

Glucommander-Guided Intravenous Insulin Infusion

Intervention: Glucommander-Guided Intravenous Insulin Infusion (Procedure)

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.

Intervention: Standard Intravenous Insulin Infusion (Procedure)

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.

Intervention: Simple Calculated Intravenous Insulin Infusion (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gary Iwamoto

Principal Investigator

University of New Mexico

Study Sites (3)

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