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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Shandong First Medical University
RECRUITING
Jinan
Contact Information
Primary
Bei Wang
wangbei1224@126.com
(86)+18853182401
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 27
Related Therapeutic Areas
Sponsors
Leads: Bei Wang

This content was sourced from clinicaltrials.gov