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临床试验/NCT03314272
NCT03314272已完成不适用

Automated Versus Conventional Perioperative Glycemic Control in Adult Diabetic Patients Undergoing Cardiopulmonary Bypass Surgery

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Percentage of patients who had hyperglycemic events

研究概览

简要总结

The purpose of this randomized controlled trial is to evaluate a fully automated algorithm for the establishment of glycemic control in diabetic patients and to compare the results with routine management of hyperglycemia in patients undergoing cardiopulmonary bypass surgery.

详细描述

Upon admission of the patients to the hospital, demographic and physiological data will be collected including waist circumference and BMI. A set of baseline laboratory tests will be done for each patient including: glucose level, Hba1c, lipid profile, creatinine level, liver enzymes and micro albumin/creatinine urinary ratio.

Patients will be asked about the presence of any diabetes complications: nephropathy, retinopathy and/or neuropathy.

In the induction room, an intravenous cannula will be inserted by an experienced anesthesiology staff or resident. A three way stopcock will be connected directly to the cannula. Standard monitors (ECG, non-invasive blood pressure and oxygen saturation) will be connected to the patient. An arterial line will be inserted by the anesthesia resident under sterile conditions using 20 gauge angiocatheter.

General anesthesia will be started. A baseline glucose level will be taken from a blood gas sample, from the arterial line inserted at the beginning of the surgery.

In the Control group, patients' glucose levels will be managed as per the anesthesiologist and/or the anesthesia resident in charge of intraoperative anesthesia management of the patients. The patient will be given actrapid insulin using the glucose sliding scale for diabetic patients as set by the protocol set at AUBMC (mentioned in methodology).

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
Single (Participant)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type I or type II diabetic patients from both genders aged between 40 - 75 years, who are ASA III-IV undergoing Cardiopulmonary Bypass surgery under general anesthesia for more than 4 hours and requiring the insertion of an arterial line.

排除标准

  • Critically ill patients ASA V
  • Pregnant patients
  • Patients' refusal to consent
  • Emergency or lifesaving cases

结局指标

主要结局

Percentage of patients who had hyperglycemic events

时间窗: Throughout the surgery periodThroughout the surgery period and postoperatively (admission to the CSU)

At least one hyperglycemic event over the surgery time

Percentage of patients who will have a serum glucose level between 140-180mg/dl during surgery.

时间窗: Throughout the surgery period and postoperatively (admission to the CSU)

The reduction of this percentage to less than 10% with the fully automated algorithm as clinically significant

Percentage of patients who had hypoglycemic events

时间窗: Throughout the surgery periodThroughout the surgery period and postoperatively (admission to the CSU)

At least one hypoglycemic event over the surgery time

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

Roland Kaddoum

Associate Professor Department of Anesthesiology/ Director of Pediatric Anesthesia/ Director of Operating Room

American University of Beirut Medical Center

研究点 (1)

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