Clinical trial NCT05538234: Biomarkers of Kidney Function in Transplant Medicine
Official title: Biomarkers of Kidney Function in Transplant Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: organ donor
organ recipient
transplant medicine
acute kidney injury
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Living and deceased organ donors, organ recipients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of kidney dysfunction biomarkers
timeFrame: up to 90 days after the procedure
Secondary outcomes:
measure: Comparison of levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death
timeFrame: during baseline data collection
measure: Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia
timeFrame: during organ harvesting
measure: Predictive value of Acute Kidney Injury biomarkers in organ recipients
timeFrame: up to 90 days after transplantation
measure: Association between donor kidney dysfunction with selected risk factors
timeFrame: up to 90 days after transplantation
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Peter Sklienka, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: