Multimodal ultrasound of donor kidneys to predict early post-transplant renal insufficiency

Multimodal Ultrasound Assessment of Kidneys From Donation After Brain Death (DBD) to Predict the Risk Model of Early Postoperative Renal Insufficiency in Renal Transplantation

We will try to see if ultrasound scans of kidneys from brain-dead donors can predict which transplant recipients will have kidney dysfunction within the first year after transplantation.

Quick facts

• Study type: Observational
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07090512 on ClinicalTrials.gov

What this trial studies

This observational study will collect multimodal ultrasound measurements from kidneys of brain-dead donors before donation and link those data to recipient outcomes. Donor ultrasound will include conventional gray-scale and Doppler measures and other sonographic parameters as available, and recipients will be followed for one year to track renal function (GFR ≤ 60 mL/min/1.73 m2). Statistical and machine-learning methods will be used to build a predictive model for early postoperative renal insufficiency. The protocol is single-center, conducted at The First Affiliated Hospital of Shandong First Medical University using routine pre-donation ultrasonography.

Who should consider this trial

Good fit: Ideal candidates are adult (≥18) allogeneic kidney transplant recipients who receive a kidney from a brain-dead donor at The First Affiliated Hospital of Shandong First Medical University and consent to follow-up.

Not a fit: Patients receiving living-donor kidneys, pediatric recipients under 18, or transplants performed at other hospitals are not eligible and would not benefit from this protocol.

Why it matters

Potential benefit: If successful, pre-donation ultrasound could help identify higher-risk donor kidneys so clinicians can adjust organ allocation or perioperative care to reduce early graft dysfunction.

How similar studies have performed: Some prior work has linked specific ultrasound features to graft outcomes, but using multimodal ultrasound of brain-dead donor kidneys to predict early post-transplant renal insufficiency is relatively novel and not yet widely validated.

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.

Where this trial is running

Jinan, Shandong

• The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Bei Wang

Conditions Occurrence of Renal Dysfunction) in Renal Transplant Recipients Within One Year After Kidney Transplantation