The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000, China
Location status: Recruiting
NCT Number: NCT07090512
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Jinan, Shandong, 250000, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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):
Expanded Criteria Donor (ECD):
② Age 50-59 years with two of the following three criteria:
Signed informed consent form.
Exclusion criteria
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.
Multimodal ultrasound data collection will be conducted on all organ donors meeting the research criteria.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Bei Wang
Other
Multimodal Ultrasound Assessment of Kidneys From Donation After Brain Death (DBD) to Predict the Risk Model of Early Postoperative Renal Insufficiency in Renal Transplantation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.