Comparing Glycemic Control Efficacy Between the National Health System and Suez Canal University Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time needed to achieve the target blood glucose (80-180)
研究概览
简要总结
The goal of clinical trial is to improve the adequacy of blood sugar control in diabetic critically ill adult patients who admitted to the intensive care unit(ICU) in Suez Canal University (SCU) hospitals by comparing glycemic control efficacy between the NHS in the UK and suggested SCU Protocols of Intravenous Insulin Infusion.
The main questions it aims to answer are:
Is SCU protocol of Intravenous Insulin Infusion more effective than NHS protocol in achieving blood glucose control targets in critically ill adult patients?
Researchers will compare glycemic control efficacy between the NHS in UK and suggested SCU Protocols of Intravenous Insulin Infusion for critically ill Adults in ICU to determine the best protocol in achieving good blood glucose control in diabetic critically ill adult patients in SCU Hospitals.
详细描述
Patients will be randomized into 2 equal groups; Group 1 (SCU group) will follow the SCU protocol of Intravenous Insulin Infusion in diabetic critically ill patients Group 2 (NHS group) will follow the NHS protocol of Intravenous Insulin Infusion in critically ill diabetic patients in UK.
Randomization will be done using a web randomizer and the randomization sequence will be concealed in numbered opaque envelopes that will be opened after patient enrollment to define his or her group assignment.
In both groups, control of blood glucose will be achieved with the use of an intravenous infusion of regular insulin in saline. Insulin will be administered, reduced, or discontinued according to the protocol in the different groups.
Two nurses must check and prepare the variable rate intravenous insulin infusion (VRIII) and every time the rate of infusion is changed. Insulin must be drawn up using an insulin syringe to draw up 50 units of prescribed Human Act rapid insulin and add to 49.5 ml of 0.9% sodium chloride in a 50 ml syringe. Mix thoroughly; this will provide a concentration of 1 unit / 1 ml.
VRIII will be stopped when RBS <80mg/dl and repeat the measure of RBS after one hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who admitted to the hospital with a potentially life-threatening condition (Critically ill patients) with HbA1C >6.0.
排除标准
- •DKA patients.
- •Pregnant or breast-feeding patients.
- •Hyperosmolar Non-Ketotic Coma.
研究组 & 干预措施
Suez Canal University variable rate Protocol
Variable rate intravenous insulin infusion will be administrated according to random blood glucose and adjusted body weight (ABW).
ABW = IBW + 0.33x (actual body weight - IBW)
If the RBS level is 80 - 200 mg/dl, the Insulin infusion rate = RBS/ 100, and for insulin-sensitive patients = RBS/150 If the RBS level is 201 - 250 mg/dl, the Insulin infusion rate = RBS/ 80, and for insulin-sensitive patients = RBS/80 If the RBS level is 251 - 300 mg/dl, the Insulin infusion rate = RBS/ 60, and for insulin-sensitive patients = RBS/60 If the RBS level > 300 mg/dl, the Insulin infusion rate = 0.1 ml /kg/h adjusted body weight (Max: 10 unit/h)
干预措施: Insulin infusion protocol (Procedure)
NHS group
If the RBS level is 72- 144 mg/dl, the Insulin infusion rate = 1 ml/hr, for insulin-sensitive patients 0.5 ml/hr, and for Insulin resistance patients = 2 ml/hr If the RBS level is 145- 216mg/dl, the Insulin infusion rate = 2 ml/hr, for insulin-sensitive patients 1 ml/hr, and for Insulin resistance patients = 4 ml/hr If the RBS level is 217- 288 mg/dl, the Insulin infusion rate = 4 ml/hr, for insulin-sensitive patients 2 ml/hr, and for Insulin resistance patients = 6 ml/hr If the RBS level is 289- 360 mg/dl, the Insulin infusion rate = 5 ml/hr, for insulin-sensitive patients 3 ml/hr, and for Insulin resistance patients = 7 ml/hr If the RBS level is 361- 432 mg/dl, the Insulin infusion rate = 6 ml/hr, for insulin-sensitive patients 4 ml/hr, and for Insulin resistance patients = 8 ml/hr If the RBS level is >433 mg/dl, the Insulin infusion rate = 8 ml/hr, for insulin-sensitive patients 6 ml/hr, and for Insulin resistance patients = 10 ml/hr
干预措施: Insulin infusion protocol (Procedure)
结局指标
主要结局
Time needed to achieve the target blood glucose (80-180)
时间窗: up to 28 days
Assess the time needed to achieve the target blood glucose (80-180) in both protocols of intravenous insulin infusion in management of hyperglycemia in diabetic critically ill patients.
次要结局
- Assess the effect of different factors in the management of hyperglycemia in critical ill patients.(up to 28 days)
- Assess the incidence of hypoglycemia among the patients of both groups.(up to 28 days)
- Compare Ventilator Free Days between two groups.(up to 28 days)
- Compare the ICU stay and hospital stay between the two groups.(up to 28 days)
- Compare ICU and 30 days Mortality rates between the two groups.(30 days)
研究者
Aiman Al-Touny
Lecturer of Anesthesia and Intensive Care
Suez Canal University