Multimodal Ultrasound in DBD Kidneys for Predicting Early Postoperative Renal Insufficiency Risk
Recruiting now
Conditions studied: Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation
In brief
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.
Key facts
- Study ID
- NCT07090512
- Run by
- Bei Wang
- People needed
- 27
- Starts
- 2025-01-01
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2025-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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