Controlled Terminal Reperfusion With Cold Preservation Solution in the cDCD III Donor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Speed of administration of the preservation solution (mL/min)
研究概览
简要总结
The goal of this observational study is to describe the details of a controlled administration strategy of cold preservation solution or oxygenated cold preservation solution at the end of Abdominal Normothermic Regional Perfusion (A-NRP) in Controlled Donation afeter Circulatory determination of Death (cDCD) III donors.
The main purpose is to:
develope a standardized protocol for this type of donor
Data collected from partecipants, deceased donors belonging to cDCD III category, willl be analysed through descriptive stastistics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Deceased donor screened for death according to category III cardiovascular criteria, according to the modified Maastricht classification, procured and subjected to Abdominal Normothermic Regional Perfusion (A-NRP);
- •Donor risk assessment as standard or negligible/acceptable non-standard risk, according to the nomenclature and guidelines of the National Transplant Center (risk definition is established by the CRT-ER, possibly after consulting with the national second opinion)
排除标准
- •Presence of absolute contraindications to organ donation;
- •Dissent to donation expressed during life;
- •Opposition by eligible family members unless specifically expressing their wishes;
- •Unacceptable risk according to the National Transplant Center (CNT) guidelines;
- •Lack of authorization from the Prosecutor's Office in cases where required;
- •Infeasibility of the controlled administration of cold preservation solution with or without oxygenation, in the judgment of the first operator and/or the perfusionist in charge.
结局指标
主要结局
Speed of administration of the preservation solution (mL/min)
时间窗: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.
Time required for administration of the preservation solution (h and min)
时间窗: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.
Occurence and type of mechanical complications (involving the extracorporeal circuit or the perfusion system in use) during controleld adminsitration of the preservation solution
时间窗: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.
Inability to perform reperfusion through the extracorporeal circuit and specific reasons
时间窗: The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.
次要结局
- Partial pressure of O2 (mm Hg) in the perfusate measured during perfusion at the end of the first bag of preservation solution and at the end of the last bag of preservation solution(1 year and 3 months)
- Partial pressure of O2 (mm Hg) in the perfusate at the start of Ex-vivo Machine Perfusion (EVMP)(The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.)
- Somatic regional oxygen saturation (rSO2) measured at the renal level during reperfusion(The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.)