An interventional study of Gelafundin in Hyperglycemia, sponsored by Universiti Sains Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment
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 (e.g., 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.
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's planned enrollment of 74 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Universiti Sains Malaysia is the lead sponsor of 171 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Insulin will be diluted with normal saline crystalloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment.
Insulin will be diluted with gelafundin colloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment.
Drug: Gelafundin
Insulin will be diluted with gelafundin colloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment.
Blood glucose level
Mean of blood glucose level
Time frame: At 2 hours
Blood glucose level
Mean of blood glucose level
Time frame: At 6 hours
Mortality
Mortality rate
Time frame: 14 days
Mortality
Mortality rate
Time frame: 28 days
Plan to share: No
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Universiti Sains Malaysia