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临床试验/NCT00460499
NCT00460499已完成1 期

Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control

American Heart Association1 个研究点 分布在 1 个国家目标入组 250 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
1 期
状态
已完成
入组人数
250
试验地点
1
主要终点
glycemic control

研究概览

简要总结

This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

详细描述

Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic CABG patients

排除标准

  • Renal and hepatic failure

研究组 & 干预措施

B Low dose GIK

Active Comparator

This group will have low doses of glucose and insulin

干预措施: B Low Dose GIK (Drug)

C High Dose GIK

Active Comparator

This group will have high doses of insulin and glucose

干预措施: C High Dose GIK (Drug)

A Insulin

Active Comparator

This group will receive only an intravenous insulin infusion

干预措施: A IV Insulin drip (Drug)

结局指标

主要结局

glycemic control

时间窗: 24 hours following surgery

glycemic control, postoperative morbidity, inflammatory markers

时间窗: 24 hours following surgery

次要结局

  • free fatty acid levels(24 hours following surgery)

研究者

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

Harold L. Lazar MD

Professor of Cardiothoracic Surgery

American Heart Association

研究点 (1)

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