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

NCT ID: NCT07090512

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Multimodal Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bei Wang

OTHER

Sponsor Role: lead

Responsible Party

Bei Wang

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bei Wang

Role: CONTACT

wangbei1224@126.com

（86）+18853182401

Other Identifiers

YXLL-KY-2024(172)

Identifier Type: -

Identifier Source: org_study_id