Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of blood glucose level 20 minutes after insulin administration
研究概览
简要总结
Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.
详细描述
Hyperglycemia is common during liver transplantation ,especially after graft reperfusion. Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. The primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation.
In the retrospective study, adult liver recipients (>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. The relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia.
In the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. The frequency and magnitude of glucose reduction is the primary outcome. The secondary outcome is the incidence and degree of hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver recipients who showed hyperglycemia (blood glucose >180mg/dL) after reperfusion of liver graft.
排除标准
- •pediatric patients
研究组 & 干预措施
Study group
The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
干预措施: Insulin (Drug)
结局指标
主要结局
Change of blood glucose level 20 minutes after insulin administration
时间窗: 20 minutes after insulin administration
Insulin is administered immediately after baseline hyperglycemia (blood glucose \>180 mg/dL) has been observed. Change of blood glucose level after insulin administration is calculated as (baseline glucose - glucose after insulin administration).
次要结局
未报告次要终点
研究者
Chul-Woo Jung
Prof
Seoul National University Hospital