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Recruiting NCT07090512

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal Ultrasound.
Who it may be relevant to
Registry conditions: Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • chronic allograft dysfunction [Time frame: Development of chronic allograft dysfunction within one year following kidney transplantation.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The First Affiliated Hospital of Shandong First Medical University — Jinan

Identifiers

NCT: NCT07090512 · YXLL-KY-2024(172)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗