Efficacy and Safety Between Different Dilution of Insulin

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia
• Intervention / Treatment: Drug: Gelafundin

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Recruiting
      • Mohd Zulfakar Mazlan
      • Contact: Mohd Zulfakar Mazlan, Master; Phone Number: 6104 +6097673000; Email: zulfakar@usm.my
      • Principal Investigator: Muhammad Fadhli Rusli, MD
      • Sub-Investigator: Mohd Zulfakar Mazlan, MBBS
      • Sub-Investigator: S Praveena Seevaunnamtum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose level	Mean of blood glucose level	At 2 hours
Blood glucose level	Mean of blood glucose level	At 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate	14 days
Mortality	Mortality rate	28 days

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: insulin; hyperglycemia; diluent; plastic syringe
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: InsulinUSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No