Efficacy and Safety Between Different Dilution of Insulin

Hyperglycemia Clinical Trial

Official title:

A Comparative Study of Efficacy and Safety Between Different Dilution of Insulin Infusion in Controlling Blood Sugar Level in ICU Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180824
• Other study ID #: InsulinUSM
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient admitted to ICU Hospital USM regardless of whether patient intubated or not.

2. Adult patient 18 years old and above.

3. 2 consecutive blood sugar more than 10 mmol/L including patient with diabetic ketoacidosis and hyperosmolar hyperglycaemic state.

4. Within 12 hours from admission.

5. Patient not in high inotropic support and with APACHE II score less than 17.

Exclusion Criteria:

1. Pregnancy.

2. History of any allergic from previous gelafundin infusion or known patient to have allergic towards gelafundin (allergic card, or information from relatives)

3. Post cardiac arrest or prolonged resuscitation.

4. Patient with cardiogenic shock.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Mohd Zulfakar Mazlan	Kota Bharu	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose level	Mean of blood glucose level	At 2 hours
Primary	Blood glucose level	Mean of blood glucose level	At 6 hours
Secondary	Mortality	Mortality rate	14 days
Secondary	Mortality	Mortality rate	28 days