CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
Glucommander-Guided Intravenous Insulin Infusion +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00582309
NCT00582309N/ACompleted

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 Mexico·interventional·Posted Dec 28, 2007·Updated Jun 23, 2015

In Brief

A clinical study evaluating Glucommander-Guided Intravenous Insulin Infusion, Standard Intravenous Insulin Infusion, and 1 other intervention for Hyperglycemia. Completed, enrolled 151 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperglycemia
CountriesUnited States
CollaboratorsSanofi

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2007
Enrollment StartAug 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.5 years ago

Interventions

Glucommander-Guided Intravenous Insulin Infusionprocedure

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.

Standard Intravenous Insulin Infusionprocedure

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.

Simple Calculated Intravenous Insulin Infusionprocedure

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.