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临床试验/NCT00282698
NCT00282698已完成3 期

Outcomes With Use Of Intensive Insulin Therapy In Intraoperative Management Of Hyperglycemia In Adult Patients Undergoing Cardiac Surgery

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年7月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Mayo Clinic
入组人数
400
试验地点
1
主要终点
Cardiac arrhythmias

研究概览

简要总结

Patients with or without diabetes may have high blood sugar levels due to stress response of the body during heart surgery. This study is being done to determine if maintaining normal blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney failure, stroke and prolonged time on the breathing machine (artificial ventilation) within 30 days after surgery.

详细描述

Rigorous intraoperative glycemic control may be of paramount importance in affecting outcomes after cardiac surgery. There is evidence that strict control of glucose levels postoperatively results in improved outcomes in patients undergoing cardiac surgery. There is currently no consensus on optimal management of hyperglycemia intraoperatively. The aim of this prospective randomized controlled clinical trial is to determine whether normalization of intraoperative glucose levels with insulin improves outcomes. The comparison group will be treated with current standard practice to control hyperglycemia during surgery. The primary outcome is a composite of mortality, sternal wound infections, prolonged pulmonary ventilation, cardiac arrhythmias (new-onset atrial fibrillation, heart block requiring permanent pacemaker, cardiac arrest), stroke and acute or worsening renal failure within 30 days after surgery. Secondary outcome measures are length of intensive care unit and hospital stay as well as safety and efficacy of the study insulin infusion protocol.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All subjects accepted for this study must be:
  • •>=18 years of age
  • •Undergoing an elective cardiac surgical procedure

排除标准

  • •Subjects who have one or more of the following will be excluded from the study:
  • •Undergoing surgery not utilizing cardiopulmonary bypass
  • •Unable to grant informed consent or comply with study procedure
  • •Undergoing emergency open heart-surgery
  • •3. Are allergic to any of the excipients in insulin

结局指标

主要结局

Cardiac arrhythmias

Renal failure

Mortality

Sternal wound infections

Stroke

次要结局

  • Lenght of intensive care unit stay
  • Length of hospital stay
  • Safety of study insulin infusion
  • Efficacy of study insulin infusion

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (1)

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