Biomarkers of Kidney Function in Transplant Medicine

Recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT05538234
• Lead Sponsor: University Hospital Ostrava

Brief Summary

Biomarkers of kidney function in transplant medicine is an international, multicentre, observational, non-interventional study.

The project is aimed at monitoring biomarkers of acute kidney dysfunction in deceased organ donors, living organ donors, and organ recipients.

Detailed Description

The study is observational, without any changes from the standard care, including only selected laboratory assessments, from standard blood samples collected from the donors/recipients.

Informed consent will be required from living donors and recipients.

The mainly used current criteria of organ acceptability in transplant medicine include urine output and laboratory parameters of acute kidney dysfunction - serum levels of urea and creatinine. Literary sources show that these classic criteria of kidney dysfunction develop only with a significant reduction of (glomerular and tubular) kidney functions and return to normal only slowly after the function of the kidneys has been restored.

New possibilities of early kidney dysfunction diagnostics are being studied, using more sensitive tests - determination of biomarkers of acute kidney dysfunction. These may serve as decisive criteria for the safe use of organs from so-called marginal donors and identify early serious impairment of kidney function in donors with preserved urine output, without fulfilled criteria of acute kidney injury.

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Study Start: 2023-01-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age 18+
• signed Informed Consent in case of living organ donors and recipients
• fulfillment of all legal requirements for organ harvesting from a deceased donor
• fulfillment of all ethical principles of end-of-life patient care
• medical suitability of organs for transplant use

Exclusion Criteria

• disapproval of family members with the enrolment of the patient in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of kidney dysfunction biomarkers	up to 90 days after the procedure	Sensitivity of kidney dysfunction biomarkers will be assessed using the Kidney Donor Risk Index and Kidney Donor Profile Index

Secondary Outcome Measures

Name	Time	Method
Comparison of levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death	during baseline data collection	levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death will be assessed.
Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia	during organ harvesting	Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia will be assessed.
Predictive value of Acute Kidney Injury biomarkers in organ recipients	up to 90 days after transplantation	The predictive value of Acute Kidney Injury biomarkers in organ recipients for worsened function of the transplanted kidney will be assessed
Association between donor kidney dysfunction with selected risk factors	up to 90 days after transplantation	Association between donor kidney dysfunction with selected risk factors will be assessed (ion disbalance, circulatory instability)

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia