Biomarkers of Kidney Function in Transplant Medicine

University Hospital Ostrava

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Other: Medical information during organ harvesting/transplantation; Procedure: Organ harvesting; Diagnostic Test: Laboratory values - 12 hours after reperfusion; Procedure: Organ transplantation; Diagnostic Test: Laboratory values - 90 days after reperfusion; Diagnostic Test: Laboratory values - baseline; Diagnostic Test: Laboratory values - 7 days after reperfusion; Diagnostic Test: Laboratory values - 48 hours after reperfusion; Other: Medical information 12 hours before organ harvesting

Study type: Observational

Funder types: Other

Identifiers

NCT05538234

KARIM-827/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Non-living organ donors

Description:

Group of non-living donors

Treatment:

Other: Medical information 12 hours before organ harvesting

Diagnostic Test: Laboratory values - baseline

Other: Medical information during organ harvesting/transplantation

Procedure: Organ harvesting

Living organ donors

Description:

Group of living organ donors

Treatment:

Diagnostic Test: Laboratory values - 7 days after reperfusion

Diagnostic Test: Laboratory values - 48 hours after reperfusion

Diagnostic Test: Laboratory values - 12 hours after reperfusion

Diagnostic Test: Laboratory values - baseline

Other: Medical information during organ harvesting/transplantation

Procedure: Organ harvesting

Diagnostic Test: Laboratory values - 90 days after reperfusion

Organ recipients

Description:

Group of organ recipients

Treatment:

Diagnostic Test: Laboratory values - 7 days after reperfusion

Diagnostic Test: Laboratory values - 48 hours after reperfusion

Diagnostic Test: Laboratory values - 12 hours after reperfusion

Diagnostic Test: Laboratory values - baseline

Other: Medical information during organ harvesting/transplantation

Procedure: Organ transplantation

Diagnostic Test: Laboratory values - 90 days after reperfusion