Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394524
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2006-10-31
Brief Title:
Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Trial Between a Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a multicenter prospective open-label randomized study to compare the safety and efficacy of continuous insulin infusion CII via a computer-guidedGlucommander and a standard paper form protocol among the patients hospitalized in a medical intensive care unit ICU
Detailed Description:
Increasing evidence from observational studies in hospitalized patients with and without diabetes indicates that hyperglycemia is a predictor of poor outcome Blood glucose control with intensive insulin therapy in patients with acute critical illness reduces the risk of multiorgan failure and systemic infection 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 andor use of total parenteral nutrition In these settings the intravenous route for insulin administration has been considered superior than 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 these algorithms and formulas however may be confusing and difficult to follow and may increase the risk of dosing errors To facilitate patients 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 of such computer-derived insulin infusion protocol which has been used successfully in over 5802 patients with diabetes between 1984 and 1998 The study hypothesizes that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol will facilitate smoother glycemic control with a lower rate of hypoglycemic events than treatment following a standard insulin infusion algorithm in critically ill patients in medical the ICU The study also aims to determine differences in glycemic control between treatment with a computer-guided intravenous infusion protocol Glucommander and a standard insulin infusion algorithm in critically ill patients in the ICU
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 andor use of total parenteral nutrition In these settings the intravenous route for insulin administration has been considered superior than 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 these algorithms and formulas however may be confusing and difficult to follow and may increase the risk of dosing errors To facilitate patients 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 of such computer-derived insulin infusion protocol which has been used successfully in over 5802 patients with diabetes between 1984 and 1998 The study hypothesizes that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol will facilitate smoother glycemic control with a lower rate of hypoglycemic events than treatment following a standard insulin infusion algorithm in critically ill patients in medical the ICU The study also aims to determine differences in glycemic control between treatment with a computer-guided intravenous infusion protocol Glucommander and a standard insulin infusion algorithm in critically ill patients in the ICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 830-2005 | OTHER | Emory University | None |