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临床试验/NCT07056088
NCT07056088尚未招募不适用

A Randomized Controlled Trial Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses

King Faisal Specialist Hospital & Research Center0 个研究点目标入组 384 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
384
主要终点
Rate of severe hypoglycemia

研究概览

简要总结

Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Currently, there is no consensus on the best method for blood glucose control during cardiac surgery. This proposal aims to perform a randomized controlled trial to compare blood glucose control intraoperatively using an insulin drip versus insulin boluses. The primary objective of the study is to compare blood glucose control intraoperatively between patients who receive insulin drip and patients who receive insulin boluses during adult cardiac surgery. This study will be a randomized controlled trial in which adult patients undergoing cardiac surgery will be randomized into two groups: insulin drip and insulin boluses. Patients with a history of diabetes or those currently taking antidiabetic medications will be included in the study. This randomized controlled trial will provide valuable information on the optimal method for achieving blood glucose control intraoperatively. The results of this study may help improve patient outcomes and reduce the incidence of postoperative complications.

详细描述

Study Title:

A Randomized Controlled Trial Comparing Intraoperative Blood Glucose Control Between Insulin Drip Versus Insulin Boluses in Adult Cardiac Surgery Patients

Sponsor and Funding:

Sponsor: None

Funding Organization: King Faisal Specialist Hospital & Research Center, Jeddah

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • All adult patients (above 18 y of age undergoing Cardiac surgery with preoperative blood glucose level (80 -180 mg/dL)
  • Patient with History of diabetes and those taking antidiabetics medications.

排除标准

  • Patients with known allergy or insulin intolerance.
  • Patients with severe hepatic Dysfunction.
  • Patient with History of hypoglycemic events in the past 6 month prior to surgery.

研究组 & 干预措施

Insulin drip

Experimental

干预措施: Insulin Drip Therapy (Drug)

Insulin boluses

Other

Control group

干预措施: Insulin boluses (Drug)

结局指标

主要结局

Rate of severe hypoglycemia

时间窗: one year

次要结局

  • Duration of ICU stay(24 hours)
  • The incidence of wound infection(7-30 days)
  • lactate clearance(From the end of surgery to 6 hours postoperatively)

研究者

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

Mohammed Alrefai

Principal Investigator

King Faisal Specialist Hospital & Research Center

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