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临床试验/NCT06180824
NCT06180824招募中不适用

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

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年1月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1
主要终点
Blood glucose level

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient admitted to ICU Hospital USM regardless of whether patient intubated or not.
  • Adult patient 18 years old and above.
  • 2 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Gelafundin (Drug)

结局指标

主要结局

Blood glucose level

时间窗: At 6 hours

Mean of blood glucose level

次要结局

  • Mortality(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohd Zulfakar Mazlan, MBBS

Associate Prof Dr

Universiti Sains Malaysia

研究点 (1)

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