NCT05538234

Biomarkers of Kidney Function in Transplant Medicine

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Laboratory values - baseline	Baseline laboratory values will be obtained
OTHER	Medical information 12 hours before organ harvesting	* average hourly diuresis * hypotension MAP\<65 Torr longer than 30 minutes (YES/NO) * Furosemide administration (YES/NO) * Mannitol administration (YES/NO) * administration of anti-diuretic hormone (YES/NO) * administration of vasopressors (YES/NO) * polyuria \>3ml/kg/h (YES/NO) * nephrotoxic agents during hospitalization (YES/NO)
DIAGNOSTIC_TEST	Laboratory values - 12 hours after reperfusion	Laboratory values will be obtained 12 hours after reperfusion
DIAGNOSTIC_TEST	Laboratory values - 48 hours after reperfusion	Laboratory values will be obtained 48 hours after reperfusion
DIAGNOSTIC_TEST	Laboratory values - 7 days after reperfusion	Laboratory values will be obtained 7 days after reperfusion
DIAGNOSTIC_TEST	Laboratory values - 90 days after reperfusion	Laboratory values will be obtained 90 days after reperfusion
OTHER	Medical information during organ harvesting/transplantation	Medical information during organ harvesting/transplantation * hypotension MAP 65 Torr \> 5 minutes (YES/NO) * vasopressor support (YES/NO, duration in minutes)
PROCEDURE	Organ harvesting	Organ harvesting for transplant
PROCEDURE	Organ transplantation	Transplantation of the harvested organ

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2022-09-13
• Last updated: 2023-09-07

Locations

1 site across 1 country: Czechia