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NCT Number: NCT07090512

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multimodal ultrasound

Diagnostic Test

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

Primary outcomes

  1. chronic allograft dysfunction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bei Wang

CONTACT

[email protected]

(86)+18853182401

Sponsors and collaborators

Lead sponsor

Bei Wang

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.