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临床试验/NCT05155917
NCT05155917Unknown2 期

Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care

Changhua Christian Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
70
试验地点
1
主要终点
the rates of rebound hyperglycemia

研究概览

简要总结

The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown.

We assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

详细描述

Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are hyperglycemic crises sharing similar clinical features including hyperglycemia, dehydration and electrolytes abnormalities. Hyperglycemia results from relative deficient circulating insulin and oversecretion of glucagon, catecholamines, cortisol, and growth hormone. Glycosuria induced osmotic diuresis leads to dehydration and electrolyte abnormalities. Diabetic ketoacidosis is also characterized by increased gluconeogenesis, lipolysis, ketogenesis, and decreased glycolysis.[1] In critically ill and mentally obtunded patients with DKA or hyperosmolar hyperglycemia, continuous intravenous insulin is the standard of care.[2] Administration of subcutaneous insulin glargine during intravenous insulin infusion shortened the time of DKA correction and significantly decreased hyperglycemia after discontinuation of the intravenous insulin. [3, 4]The differences in rebound hyperglycemia rates were highly significant for at least 12 hours after transition to subcutaneous insulin regimens in the DKA and non-DKA patients as well as in organ transplant patients receiving steroids. [4] However, the previous studies only enrolled small numbers of patients(without Asian population) and excluded newly diagnosed hyperglycemia or critical illness and pregnant women. The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown.

The investigators assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

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

  • Patients with hyperglycemic crisis(DKA, HHS or mixing type) receiving iv insulin infusion
  • Patients admitted to the Changhua Christian Hospital Medical Intensive Care Unit(MICU)

排除标准

  • pregnancy
  • age under 18 years old

研究组 & 干预措施

basal insulin and insulin pump

Experimental

Subjects in the intervention group received insulin glargine sc (0.25 U/kg body weight) within 6 h of initiation of iv insulin infusion, as close to initiation of iv insulin as possible.

干预措施: Insulin Glargine 300 UNT/ML [Toujeo] (Drug)

结局指标

主要结局

the rates of rebound hyperglycemia

时间窗: "the next 12 hours" after ceasing insulin infusion

the rates of hyperglycemia( serum glucose \>300mg/dl) after ceasing insulin infusion

the rates of hypoglycemia

时间窗: "the next 12 hours" after ceasing insulin infusion

the rates of hypoglycemia( serum glucose \<70mg/dl) during insulin infusion

次要结局

  • insulin infusion time('the next 12 hours' after ceasing insulin infusion)
  • ICU length of stay(through study completion, an average of 1 year)
  • ventilator use days(through study completion, an average of 1 year)
  • ICU Mortality rate(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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