NCT01001273Unknown不适用
Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The number of post-transplants all complications up to 30 days (Clavien grading).
研究概览
简要总结
This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.
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
- 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
- •Male or female patient over 18 years of age
- •Patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant
- •Able to give written informed consent prior to any study specific procedure
排除标准
- •Multi-organ transplant other than kidney transplant
- •No central venous access available to deliver the D20W solution
研究组 & 干预措施
Study Group
Experimental
Hyperinsulinemic Normoglycemic Clamp will be started at the time of surgery (before incision) and will be continue for 3 days.
干预措施: Hyperinsulinemic Normoglycemic Clamp (Other)
Control Group
No Intervention
Patients in the control group will receive standard care.
结局指标
主要结局
The number of post-transplants all complications up to 30 days (Clavien grading).
时间窗: 30 days post-operative
次要结局
- The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)(30 days post-op)
- The length of hospital stay (days)(Length of hospital stay (day 1 until discharge))
研究者
研究点 (1)
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