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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-living organ donors | Group of non-living donors |
| |
| Living organ donors | Group of living organ donors |
| |
| Organ recipients | Group of organ recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory values - baseline | Diagnostic Test | Baseline laboratory values will be obtained |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of kidney dysfunction biomarkers | Sensitivity of kidney dysfunction biomarkers will be assessed using the Kidney Donor Risk Index and Kidney Donor Profile Index | up to 90 days after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death | levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death will be assessed. | during baseline data collection |
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Inclusion Criteria:
Exclusion Criteria:
- disapproval of family members with the enrolment of the patient in the study
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Living and deceased organ donors, organ recipients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Peter Sklienka, MD, Ph.D. | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
Individual participant data may be provided upon request.
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Blood samples will be collected from the study participants.
| Medical information 12 hours before organ harvesting | Other |
|
|
| Laboratory values - 12 hours after reperfusion | Diagnostic Test | Laboratory values will be obtained 12 hours after reperfusion |
|
| Laboratory values - 48 hours after reperfusion | Diagnostic Test | Laboratory values will be obtained 48 hours after reperfusion |
|
| Laboratory values - 7 days after reperfusion | Diagnostic Test | Laboratory values will be obtained 7 days after reperfusion |
|
| Laboratory values - 90 days after reperfusion | Diagnostic Test | Laboratory values will be obtained 90 days after reperfusion |
|
| Medical information during organ harvesting/transplantation | Other | Medical information during organ harvesting/transplantation
|
|
| Organ harvesting | Procedure | Organ harvesting for transplant |
|
| Organ transplantation | Procedure | Transplantation of the harvested organ |
|
| Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia |
Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia will be assessed. |
| during organ harvesting |
| Predictive value of Acute Kidney Injury biomarkers in organ recipients | The predictive value of Acute Kidney Injury biomarkers in organ recipients for worsened function of the transplanted kidney will be assessed | up to 90 days after transplantation |
| Association between donor kidney dysfunction with selected risk factors | Association between donor kidney dysfunction with selected risk factors will be assessed (ion disbalance, circulatory instability) | up to 90 days after transplantation |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| D020858 | Tissue and Organ Harvesting |
| D016377 | Organ Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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