跳至主要内容
临床试验/NCT00338104
NCT00338104已完成4 期

Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

Northwestern University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
75
试验地点
1
主要终点
Percentage of Blood Glucose Values Between 80 - 140

研究概览

简要总结

The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design.

Note: Lantus insulin is the proprietary name for glargine insulin.

详细描述

Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart.

Subjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows:

  1. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;
  2. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;
  3. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion.

The glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fasting glucose > 100 mg/dl
  • Patients on surgical services or in intensive care units receiving intravenous insulin

排除标准

  • Inability to obtain informed consent from patient or next-of-kin
  • Allergy to insulin
  • Participation in another research study
  • Patients for whom there are "do-not-resuscitate" orders

研究组 & 干预措施

40% Glargine

Experimental

Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.

干预措施: insulin glargine (Drug)

60% Glargine

Experimental

Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.

干预措施: insulin glargine (Drug)

80% Glargine

Experimental

Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.

干预措施: insulin glargine (Drug)

结局指标

主要结局

Percentage of Blood Glucose Values Between 80 - 140

时间窗: First 24 hours after conversion

Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL

次要结局

  • Percentage of Glucose Values < 50 mg/dL(First 24 hours after conversion)
  • Percentage of Glucose Levels > 180 mg/dL(First 24 hours after conversion)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Conversion of Hyperglycemic Patients Being Treated... | 临床试验