Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Poor Graft Function After Kidney Transplant
研究概览
简要总结
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function.
详细描述
Population- Our study population will include all adult diabetic patients undergoing deceased donor renal transplantation or living donor transplantation in which a swap requires transportation and resulting cold storage time. This will ensure a reasonable incidence of our primary outcome (poor short term graft function) and eliminate the potential risk of treating non-diabetic patients with insulin infusions. Patients already enrolled in a drug trial designed to study the impact of the drug on graft function will be excluded.
Study Design- This will be a randomized control trial. Recipients will be randomized to either tight peri-operative glucose control or standard management.
Methods
Randomization Protocol- In order to ensure that patients are equally distributed between groups, we will use block randomization. Blocks of 4 patients will be created with the total number of experimental versus control assignments being equal across blocks. Patients will then be randomly assigned to a block.
Interventions- The study group will be treated with an insulin infusion to achieve tight glycemic control (100-140mg/dL). Each study patient will be started on an insulin infusion prior to their operation. This infusion will continue throughout the operation and for 24 hours after completion of the transplant. Glucose control will then be left to the discretion of the primary team.
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
- •adult patients
- •end stage renal disease undergoing cadaveric renal transplant
排除标准
- •enrolled in concurrent study to test impact of a drug on graft function after transplant
研究组 & 干预措施
Tight glucose control
Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.
干预措施: Insulin (Drug)
Standard glucose control
Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.
干预措施: Insulin, Asp(B28)- (Drug)
结局指标
主要结局
Incidence of Poor Graft Function After Kidney Transplant
时间窗: 7 days after transplant
Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of \<10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine \>3 mg/dL 5 days after transplant without dialysis)
次要结局
未报告次要终点