Efficacy and Safety Between Different Dilution of Insulin

NCT06180824 | Recruiting

• 1 other identifier: InsulinUSM
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

insulin; hyperglycemia; diluent; plastic syringe

Outcome Measures

Primary Outcomes (2)

• Blood glucose level

  Mean of blood glucose level

  At 2 hours

• Blood glucose level

  Mean of blood glucose level

  At 6 hours

Secondary Outcomes (2)

• Mortality

  14 days

• Mortality

  28 days

Study Arms (2)

normal saline

NO INTERVENTION

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.

gelafundin

ACTIVE COMPARATOR

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

Interventions

Gelafundin 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.

gelafundin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient admitted to ICU Hospital USM regardless of whether patient intubated or not.
• Adult patient 18 years old and above.
• consecutive blood sugar more than 10 mmol/L including patient with diabetic ketoacidosis and hyperosmolar hyperglycaemic state.
• Within 12 hours from admission.
• Patient not in high inotropic support and with APACHE II score less than 17.

You may not qualify if:

• Pregnancy.
• History of any allergic from previous gelafundin infusion or known patient to have allergic towards gelafundin (allergic card, or information from relatives)
• Post cardiac arrest or prolonged resuscitation.
• Patient with cardiogenic shock.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Mohd Zulfakar Mazlan

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof Dr

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 26, 2023
• Study Start: January 9, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)