跳至主要内容
临床试验/NCT00166491
NCT00166491已完成不适用

Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2005年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
238
试验地点
2
主要终点
Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]

研究概览

简要总结

The purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin. In patients admitted to the intensive care unit, blood sugar levels often rise due to the stress of illness or surgery. Studies have shown that patients do better if their blood sugar is kept normal. In order to maintain normal blood sugar levels, the investigators often give insulin (a substance made by the body), and they decide how much to give based on how high the blood sugar is. This study will compare two different ways of deciding how much insulin to give and compare how well each method keeps the blood sugar in a normal range. Both ways of controlling blood sugar are institutionally-approved protocols and part of routine care.

详细描述

Improved outcomes have been demonstrated with tight control of blood glucose in critically ill patients. A number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit (ICU). Despite the numerous published algorithms, no study has investigated which algorithm results in optimal glycemic control in critically ill patients. The purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control. We hypothesize that the protocol that allows for variable insulin administration for a given blood glucose (multiple algorithms) will be associated with more optimal glycemic control. Optimal glycemic control will be defined by time spent within a predetermined blood glucose range. In addition, the number of hypoglycemic episodes and mean and maximum blood glucose concentrations will also be measured. This trial will determine which insulin infusion algorithm is most effective in terms of glycemic control, and allow for standardization of glucose management in accordance with best practice.

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

入排标准

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

入选标准

  • All patients admitted to the 7MB D/E ICU will be eligible for this study

排除标准

  • 未提供

结局指标

主要结局

Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]

Mean blood glucose level during study period [mg/dl]

次要结局

  • Time enrolled in the trial [hours]
  • Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]
  • Number of time points below range (hypoglycemic episodes with serum glucose < 60) normalized by study period [hypoglycemic glucose determinations/total glucose determinations]
  • Maximum blood glucose level during study period [mg/dl]
  • Mean hourly intravenous (IV) insulin dose calculated daily [units/hour]

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

Loading locations...

相似试验

Comparing Two Ways of Controlling Blood Sugar With... | 临床试验