Multimodal Ultrasound Assessment of Kidneys From Donation After Brain Death (DBD) to Predict the Risk Model of Early Postoperative Renal Insufficiency in Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- chronic allograft dysfunction
研究概览
简要总结
The objective of this observational study is to investigate the multimodal ultrasound parameters of kidneys from brain-dead organ donors prior to donation, in order to construct a predictive model for assessing the risk of early transplant renal dysfunction after kidney transplantation in recipients.
The primary question this study aims to address is:
Can multimodal ultrasound data from brain-dead organ donor kidneys accurately predict early post-transplant renal dysfunction?
Ultrasonography, as a routine examination before organ donation, will be utilized, and the study results will be concluded within one year after participation in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Recipient Study Participants Age ≥18 years;
- •Underwent allogeneic kidney transplantation at this hospital;
- •Signed informed consent form.
- •Donor Study Participants Brain-deceased organ donors;
- •Completed organ donation at the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province);
- •Brain death criteria:
- •Deep coma (with clear etiology and exclusion of reversible causes);
- •Absence of brainstem reflexes;
- •No spontaneous respiration;
- •Confirmed by at least two confirmatory tests (SLSEP, EEG, TCD), with re-evaluation 12 hours after the initial determination.
- •Standard Criteria Donor (SCD):
- •Age 10-39 years;
- •Cause of death unrelated to cerebrovascular disease;
- •Serum creatinine <133 μmol/L;
- •No history of hypertension.
- •Expanded Criteria Donor (ECD):
- •Age >60 years; OR
- •② Age 50-59 years with two of the following three criteria:
- •Cause of death related to cerebrovascular disease;
- •Serum creatinine <133 μmol/L;
- •History of hypertension.
- •Signed informed consent form.
排除标准
- •Recipient Study Participants Patients with multiple kidney transplants;
- •Patients with follow-up duration less than 1 year;
- •Patients experiencing irreversible loss of graft function due to postoperative complications (e.g., rejection, thrombosis, anastomotic stenosis, infection).
- •Donor Study Participants Severe primary renal diseases (e.g., hypertensive nephropathy, diabetic nephropathy, renal tumors);
- •Cases with unavailable ultrasound imaging data:
- •Excessive respiratory motion in donors;
- •Obesity or other factors affecting imaging quality.
- •Individuals with allergic predisposition.
结局指标
主要结局
chronic allograft dysfunction
时间窗: Development of chronic allograft dysfunction within one year following kidney transplantation.
Occurrence of chronic allograft dysfunction (GFR ≤ 60mL/(min·1.73m2)) in renal transplant recipients within one year after kidney transplantation.
次要结局
未报告次要终点
研究者
Bei Wang
Chief Physician
Qianfoshan Hospital