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临床试验/NCT03033667
NCT03033667已完成不适用

Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting

Cairo University0 个研究点目标入组 63 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
主要终点
The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution

研究概览

简要总结

Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.

详细描述

Obese patients scheduled for bypass surgery randomly assigned to three groups:

Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.

Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.

Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

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

  • Adult patients (> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).
  • All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.

排除标准

  • Patients with diabetes mellitus
  • Patients on fibrates
  • Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
  • Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
  • Patients with carbohydrate or fat intolerance

结局指标

主要结局

The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution

时间窗: Over an infusion period of 10 hours preoperatively

次要结局

未报告次要终点

研究者

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

Hisham Hosny

assistant professor

Cairo University

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