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临床试验/NCT06178874
NCT06178874已完成不适用

Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月1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
已完成
入组人数
90
试验地点
1
主要终点
hyperglycemic control

研究概览

简要总结

The role of ultralong insulin in the control of the blood glucose level in diabetic patients is well known, the current study will discuss the role of ultralong insulin in controlling of hyperglycaemia in critical illness defined as failure or impending failure of an organ

详细描述

A standard monitor will be attached to the patients including 5 leads ECG, pulse oximeter, NIBP and IV line will be secured. The hemodynamic parameters will be recorded every 15 minutes.

The random blood sugar in the patients in group S will be managed using regular insulin based on a sliding scale as in Table 1 together with an Insulin Glargine, 0.2 units/kg , SC, initially to be titrated as per the clinical situation to be given at 9 PM.

The random blood sugar in the patients in group L will be managed using regular insulin based on a sliding scale as in table 1 together with an Insulin Degludec 0.2 units/kg, SC, initially to be titrated as per the clinical situation to be given at 9 PM.

The random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale THE total dose of insulin will be monitored, episodes of hypoglycaemia ' decrease of blood sugar less than 60gm/dl, the length of the hospital stay, the serum potassium level , the incidence of infection as evidenced by increase WBC or clinical evidence of infection, incidence of diabetic ketoacidosis and the incidence of acute kidney risk as evidenced by decrease of urine output < 0.5 ml/kg/hr for more than 6 hr and/or increase of the serum creatinine 1.5-2 times the baseline of Acute kidney injuries as evidenced by decrease of urine output < 0.5 ml/kg/hr for more than 12 hr and/or increase of the serum creatinine 2-3 times the baseline.

The CBC, Kidney function test, liver enzymes, serum creatinine, s.Na+, s.K+ , s.albumin, RBS will be collected on admission and every three days if there is no indication for close monitoring. Glycated haemoglobin will be collected once.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Blood glucose level >250 mg/dl for more than 24 h

排除标准

  • Age less than 18 or greater than 60 years
  • Diabetic Ketoacidosis
  • Patients with recurrent episodes of hypoglycaemia-* Stress hyperglycemia
  • Patients refusing to participate in the study.
  • Patients with renal insufficiency
  • Patients on corticosteroids

研究组 & 干预措施

group S

Active Comparator

The random blood sugar in the patients in group S will be managed using regular insulin based on a sliding scale together with an Insulin Glargine, 0.2 units/kg , SC, initially to be titrated as per the clinical situation to be given at 9 PM

干预措施: Insulin Glargine (Drug)

group S

Active Comparator

The random blood sugar in the patients in group S will be managed using regular insulin based on a sliding scale together with an Insulin Glargine, 0.2 units/kg , SC, initially to be titrated as per the clinical situation to be given at 9 PM

干预措施: Insulin regular (Drug)

Group L

Active Comparator

The random blood sugar in the patients in group L will be managed using regular insulin based on a sliding scale together with an Insulin Degludec 0.2 units/kg, SC, initially to be titrated as per the clinical situation to be given at 9 PM

干预措施: Insulin Degludec (Drug)

Group L

Active Comparator

The random blood sugar in the patients in group L will be managed using regular insulin based on a sliding scale together with an Insulin Degludec 0.2 units/kg, SC, initially to be titrated as per the clinical situation to be given at 9 PM

干预措施: Insulin regular (Drug)

Group R

Active Comparator

The random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale

干预措施: Insulin regular (Drug)

结局指标

主要结局

hyperglycemic control

时间窗: 10 days of ICU stay

the insulin dose needed for achievement of the glycemic goals by insulin degludec vs insulin Glargine in critically ill patient.

次要结局

  • length of ICU stay(from admission till discharge from ICU through a period of 2 weeks)

研究者

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

Adham Haggag

Associate proffesor

Ain Shams University

研究点 (1)

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