跳至主要内容
临床试验/NCT00795015
NCT00795015已完成4 期

Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2006年4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
93
试验地点
1
主要终点
Percent of blood glucose values in the target range 80-120 mg/dl

研究概览

简要总结

The investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.

详细描述

In 2002 we adapted the protocol described by Van den Berghe et al. for use in our own surgical intensive care unit (SICU) with a target blood glucose range from 80 to 120mg/dL. After five years of implementation, we were able to achieve a mean BG of 117 mg/dL in the SICU. 2% of glucose values were <60 mg/dL in the SICU. Given the concern of safety while optimizing glycemic control, we investigated the etiologies for these hypoglycemic episodes and have found two frequent risk factors; the failure to consistently measure blood glucose every hour and in patients with end stage renal failure.

We will investigate whether a computer-based algorithm for the titration of IV insulin will translate to better clinical outcomes and less hypoglycemia. Therefore, we will conduct a prospective randomized trial comparing the Glucommander, a computer-based algorithm with our Van den Berghe protocol for titration of IV insulin in patients after cardiovascular or transplant surgery. This computer based algorithm was invented in 1984 in Atlanta by Dr. Davidson and Dr. Steed who have used it in a variety of applications of IV insulin.

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

  • s/p open heart or kidney or liver transplant surgery

排除标准

  • admission blood glucose less than 120 mg/dl

研究组 & 干预措施

leuven

Active Comparator

these patients had their IV insulin controlled by using the protocol adapted from van den Berghe et al. University of Leuven, Belgium, NEJM Nov. 2001

干预措施: insulin regular IV infusion (Drug)

leuven

Active Comparator

these patients had their IV insulin controlled by using the protocol adapted from van den Berghe et al. University of Leuven, Belgium, NEJM Nov. 2001

干预措施: IV insulin infusion (Drug)

glucommander

Active Comparator

these subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005

干预措施: insulin regular IV infusion (Drug)

glucommander

Active Comparator

these subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005

干预措施: IV insulin infusion (Drug)

结局指标

主要结局

Percent of blood glucose values in the target range 80-120 mg/dl

时间窗: first 200 hours post-op in the ICU

次要结局

  • Percent of patient days with a low blood glucose, defines as less than 60 mg/dl(200 hours while in ICU)

研究者

申办方类型
Other

研究点 (1)

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