Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166491
Status:
COMPLETED
Last Update Posted:
2011-04-18
First Post:
2005-09-12
Brief Title:
Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2011-04
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 purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin In patients admitted to the intensive care unit blood sugar levels often rise due to the stress of illness or surgery Studies have shown that patients do better if their blood sugar is kept normal In order to maintain normal blood sugar levels the investigators often give insulin a substance made by the body and they decide how much to give based on how high the blood sugar is This study will compare two different ways of deciding how much insulin to give and compare how well each method keeps the blood sugar in a normal range Both ways of controlling blood sugar are institutionally-approved protocols and part of routine care
Detailed Description:
Improved outcomes have been demonstrated with tight control of blood glucose in critically ill patients A number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit ICU Despite the numerous published algorithms no study has investigated which algorithm results in optimal glycemic control in critically ill patients The purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control We hypothesize that the protocol that allows for variable insulin administration for a given blood glucose multiple algorithms will be associated with more optimal glycemic control Optimal glycemic control will be defined by time spent within a predetermined blood glucose range In addition the number of hypoglycemic episodes and mean and maximum blood glucose concentrations will also be measured This trial will determine which insulin infusion algorithm is most effective in terms of glycemic control and allow for standardization of glucose management in accordance with best practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None