RecruitingNot Applicable

Multimodal Ultrasound in DBD Kidneys for Predicting Early Postoperative Renal Insufficiency Risk

China27 participantsStarted 2025-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 nephrop…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

chronic allograft dysfunction

Timeframe: Development of chronic allograft dysfunction within one year following kidney transplantation.

Trial details

NCT IDNCT07090512

SponsorBei Wang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Bei Wang

（86）+18853182401 wangbei1224@126.com

View on ClinicalTrials.gov More Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation trials