Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.
研究概览
简要总结
Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.
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
- •18 years of age and older
- •Undergoing liver transplant or combined liver-kidney transplant
排除标准
- •Unable to grant informed consent or comply with study procedure
- •Allergic to any of the excipients in insulin
结局指标
主要结局
Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.
时间窗: 90 days following liver transplantation.
The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.
次要结局
- Compare length of stay in the ICU and hospital in the two study groups.(90 days following liver transplantation.)
- Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.(90 days following liver transplantation.)
研究者
Gunjan Gandhi
Principal Investigator
Mayo Clinic