Remote Ischaemic Preconditioning in Transplantation (RIPTRANS) - A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 496
- 试验地点
- 1
- 主要终点
- DGF
研究概览
简要总结
Remote ischemic preconditioning (RIPC) is a concept where remotely induced ischemia produces protection against ischemia-reperfusion injury in a remote organ. RIPC has been studied extensively in animal models and heart surgery, but it's benefit in transplantation has been studied less. The primary aim of this study is to find out whether RIPC performed in a donor in donation after brain-death (DBD) could improve delayed graft function rate of kidney transplants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Donor Inclusion Criteria:
- •Brain-dead organ donor with a plan of harvesting at least one kidney
排除标准
- •Haemodynamically unstable donor
- •Age below 18 years
- •Planned organ recipients are recruited to another prospective trial, which prevents participation in this trial.
- •All organ recipients receiving organs (kidney, liver, pancreas-kidney, heart, lungs) from a randomized donor will be recruited providing that the recipient surgery is performed at Helsinki University Hospital, recipient is over 18 years old, and recipient gives written informed consent to participate in the trial.
研究组 & 干预措施
RIPC
RIPC will consist of setting a tourniquet to donor thigh and inflating it to 300mmHg four times 5 minutes with 5 minutes deflating in between each. RIPC-intervention will be performed twice: First after brain death and second time before procurement procedure.
干预措施: RIPC (Procedure)
Sham-RIPC
Sham-RIPC will consist of setting a tourniquet to donor thigh without inflating it and keeping it in place for 35 min. Sham-RIPC-intervention will be performed twice: First after brain death and second time before procurement procedure.
干预措施: Sham-RIPC (Procedure)
结局指标
主要结局
DGF
时间窗: 7 days
Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
次要结局
- Kidney allografts: BPAR(within 1 year)
- Combined Pancreas-Kidney allografts: kidney graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Liver allografts: MEAF-score at 3rd POD(3rd post-operative day)
- Pancreas allografts: Acute rejection(within 1 year)
- Lung allograft: CLAD-free survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
- Liver allografts: graft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
- Pancreas allografts: Death-censored Pancreatic allograft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
- Combined Pancreas-Kidney allografts: eGFR(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Pancreas allografts: HbA1c(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Pancreas allografts: Pancreatic allograft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
- Heart allograft: proBNP at 1 week(at 1 week)
- Heart allograft: Primary graft dysfunction(within 24 hours after transplantation)
- Heart allograft: acute rejection(within 1 year)
- Heart allograft: graft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
- Lung allograft: Primary graft dysfunction(within 72 hours)
- Lung allograft: graft survival(at 1, 2, 5, 10 and 20 year)
- Heart allograft: TnI at 6 hours(at 6 hours)
- Kidney allografts: death-censored graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Combined Pancreas-Kidney allografts: death-censored kidney graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Liver allografts: Postoperative biliary complications(within 1 year)
- Liver allografts: Posttransplantation kidney injury(within 1 week, at 3 months, 1 year)
- Liver allografts: BPAR(within 1 year)
- Kidney allografts: eGFR(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Combined Pancreas-Kidney allografts: Kidney BPAR(within 1 year)
- Kidney allografts: graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
- Heart allograft: Vasculopathy-free survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
- Lung allograft: Acute rejection(within 1 year)
研究者
Ville Sallinen
MD, PhD, Adj. Prof., Consultant
Helsinki University Central Hospital