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

NCT07090512 | Recruiting

• 1 other identifier: YXLL-KY-2024(172)
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• chronic allograft dysfunction

  Occurrence of chronic allograft dysfunction (GFR ≤ 60mL/(min·1.73m2)) in renal transplant recipients within one year after kidney transplantation.

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

Interventions

Multimodal Ultrasound DIAGNOSTIC_TEST

Multimodal ultrasound data collection will be conducted on all organ donors meeting the research criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Brain-deceased organ donors and their matched kidney transplant recipients at the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province).

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:
• 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):

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.

Sponsors & Collaborators

• Bei Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

Central Study Contacts

Bei Wang

CONTACT

（86）+18853182401; wangbei1224@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

CN (1)