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Efficacy and Safety Between Different Dilution of Insulin

NCT06180824 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180824 on ClinicalTrials.gov