Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.
研究概览
简要总结
To study whether exogenous alkaline phosphatase can prevent ischemia reperfusion injury in deceased donor kidney transplantation and will thereby decrease the duration of delayed graft function (DGF). DGF is defined as the need for dialysis that started within 7 days post-transplant, excluding single sessions for hyperkalemia.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients recipients of a donor awaiting cardiac death on the intensive care (definition of a donor cardiac death type III according to the ‘Maastricht classification’)
- •Can give written informed consent
排除标准
- •Strict vegetarians
- •History of allergy to bovine proteins
结局指标
主要结局
Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.
Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.
次要结局
- Mean duration of hospitalization after kidney transplantation
- Incidence of persistent dialysis DGF (> 14 days)
- Incidence of functional and dialysis DGF
- Duration of DGF using functional and dialysis definition and a combination of the two
- Dall of serum creatinine in the first week after transplantation
- Kidney perfusion contrast renography at day 6
- Creatinine clearance at 3 months and 1 year after transplantation
- Proteinuria at 3 months and 1 year after transplantation
- Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation
- Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months).
- Incidence of biopsy proven rejection within one year follow-up period.
- All-cause mortality at day 28 and 90 and 1 year.
研究者
Liffert Vogt
Scientific
Stichting Amsterdam UMC