Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180824
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-12-04
Brief Title:
Efficacy and Safety Between Different Dilution of Insulin
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
A Comparative Study of Efficacy and Safety Between Different Dilution of Insulin Infusion in Controlling Blood Sugar Level in ICU Patient
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Hyperglycemia associated with insulin resistance is common in critically ill patients even in those nondiabetic patients Hyperglycaemia or relative insulin deficiency or both during critical illness may directly or indirectly confer a predisposition to complications such as severe infections polyneuropathy multiple-organ failure and death Tight glycaemic control in adult long-stay critically ill patients using intensive insulin therapy reduces absolute mortality It has been reported that pronounced hyperglycemia may lead to complications in such patients although data from controlled trials are lacking However target glycaemia may be difficult to achieve in clinical practice Insulin adsorption onto infusion equipment eg infusion tubing may affect glucose control possibly leading to hyperglycemia In the use of low-level intravenous insulin infusion for treating diabetic hyperglycaemia and ketoacidosis adsorption of insulin to containers or plastic infusion apparatus results in significant losses of 60-80 of insulin in dilute physiological saline solution
Problem statement Study rationale
Up to my knowledge there is no study that demonstrate differences between types of dilution for insulin infusion in ICU patient in Malaysia thus this study is aimed to evaluate it In 2001 it has been reported that intensive insulin therapy IIT in surgical intensive care unit ICU patients was associated with reduction in mortality and morbidity as well as other associated factors There is limited study in comparing dilution of insulin in normal saline and other types of diluents
Other than that it is important to know which diluent the best is to choose for the management of hyperglycaemia in ICU patient
Problem statement Study rationale
Up to my knowledge there is no study that demonstrate differences between types of dilution for insulin infusion in ICU patient in Malaysia thus this study is aimed to evaluate it In 2001 it has been reported that intensive insulin therapy IIT in surgical intensive care unit ICU patients was associated with reduction in mortality and morbidity as well as other associated factors There is limited study in comparing dilution of insulin in normal saline and other types of diluents
Other than that it is important to know which diluent the best is to choose for the management of hyperglycaemia in ICU patient
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None