Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- • Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
研究概览
简要总结
Our objective in this study will be to determine if implementing the glucose/insulin clamp (GICT) on cadaveric organ donors can:
-
Prevent hyperglycaemia
-
Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
-
Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant
-
Assess graft function by evaluating:
-
Liver: post-transplant liver function score (PTLF)
-
Kidney: graft function as defined by UNOS (immediate graft function IGF, slow graft function SGF and delayed graft function DGF and
-
Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at day one and seven post-transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donors must be over 18 years of age
- •Brain death donors only
- •Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.
排除标准
- •Inability to obtain a research consent
- •Time interval between the start of the study and cross-clamping less than 6 hours.
- •No solid organs retrieved for transplantation
- •Diagnosed with Type 1 Diabetes
- •Donor has uncontrolled serum blood glucose levels (above 10 mmol/L) at time of inclusion
结局指标
主要结局
• Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
时间窗: during transplant
Our objective in this study will be to determine if implementing the glucose/insulin clamp (GICT) on cadaveric organ donors can: * Prevent hyperglycaemia * Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
次要结局
- Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant(1 year post-transplant)
研究者
peter metrakos
Director Multiorgan Transplant Program-MUHC
McGill University Health Centre/Research Institute of the McGill University Health Centre