Acute Kidney Injury
Conditions
Keywords
organ donor, organ recipient, transplant medicine, acute kidney injury
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.
Interventions
DIAGNOSTIC_TESTLaboratory values - baseline
Baseline laboratory values will be obtained
OTHERMedical 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_TESTLaboratory values - 12 hours after reperfusion
Laboratory values will be obtained 12 hours after reperfusion
DIAGNOSTIC_TESTLaboratory values - 48 hours after reperfusion
Laboratory values will be obtained 48 hours after reperfusion
DIAGNOSTIC_TESTLaboratory values - 7 days after reperfusion
Laboratory values will be obtained 7 days after reperfusion
DIAGNOSTIC_TESTLaboratory values - 90 days after reperfusion
Laboratory values will be obtained 90 days after reperfusion
OTHERMedical 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)
PROCEDUREOrgan harvesting
Organ harvesting for transplant
PROCEDUREOrgan transplantation
Transplantation of the harvested organ
Sponsors
University Hospital Ostrava
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed