Efficacy and Safety Between Different Dilution of Insulin

NCT ID: NCT06180824

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2024-12-31

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 (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.

Conditions

Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

normal saline

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Gelafundin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Mohd Zulfakar Mazlan, MBBS

Associate Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohd Zulfakar Mazlan

Kota Bharu, Kelantan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Facility Contacts

Mohd Zulfakar Mazlan, Master

Role: primary

zulfakar@usm.my

+6097673000 ext. 6104

Other Identifiers

InsulinUSM

Identifier Type: -

Identifier Source: org_study_id