Biomarkers of Kidney Function in Transplant Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sensitivity of kidney dysfunction biomarkers
研究概览
简要总结
Biomarkers of kidney function in transplant medicine is an international, multicentre, observational, non-interventional study.
The project is aimed at monitoring biomarkers of acute kidney dysfunction in deceased organ donors, living organ donors, and organ recipients.
详细描述
The study is observational, without any changes from the standard care, including only selected laboratory assessments, from standard blood samples collected from the donors/recipients.
Informed consent will be required from living donors and recipients.
The mainly used current criteria of organ acceptability in transplant medicine include urine output and laboratory parameters of acute kidney dysfunction - serum levels of urea and creatinine. Literary sources show that these classic criteria of kidney dysfunction develop only with a significant reduction of (glomerular and tubular) kidney functions and return to normal only slowly after the function of the kidneys has been restored.
New possibilities of early kidney dysfunction diagnostics are being studied, using more sensitive tests - determination of biomarkers of acute kidney dysfunction. These may serve as decisive criteria for the safe use of organs from so-called marginal donors and identify early serious impairment of kidney function in donors with preserved urine output, without fulfilled criteria of acute kidney injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •signed Informed Consent in case of living organ donors and recipients
- •fulfillment of all legal requirements for organ harvesting from a deceased donor
- •fulfillment of all ethical principles of end-of-life patient care
- •medical suitability of organs for transplant use
排除标准
- •disapproval of family members with the enrolment of the patient in the study
结局指标
主要结局
Sensitivity of kidney dysfunction biomarkers
时间窗: up to 90 days after the procedure
Sensitivity of kidney dysfunction biomarkers will be assessed using the Kidney Donor Risk Index and Kidney Donor Profile Index
次要结局
- Comparison of levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death(during baseline data collection)
- Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia(during organ harvesting)
- Predictive value of Acute Kidney Injury biomarkers in organ recipients(up to 90 days after transplantation)
- Association between donor kidney dysfunction with selected risk factors(up to 90 days after transplantation)