Biomarkers of Kidney Function in Transplant Medicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Biomarkers of Kidney Function in Transplant Medicine

Conditions
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Acute Kidney Injury

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-living organ donors<br>Group of non-living donors | Diagnostic Test: Laboratory values - baseline<br>* Baseline laboratory values will be obtained<br>Other: Medical information 12 hours before organ harvesting<br>* 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)<br>Other: Medical information during organ harvesting/transplantation<br>* Medical information during organ harvesting/transplantation hypotension MAP 65 Torr > 5 minutes (YES/NO) vasopressor support (YES/NO, duration in minutes)<br>Procedure: Organ harvesting<br>* Organ harvesting for transplant<br>|
| Living organ donors<br>Group of living organ donors | Diagnostic Test: Laboratory values - baseline<br>* Baseline laboratory values will be obtained<br>Diagnostic Test: Laboratory values - 12 hours after reperfusion<br>* Laboratory values will be obtained 12 hours after reperfusion<br>Diagnostic Test: Laboratory values - 48 hours after reperfusion<br>* Laboratory values will be obtained 48 hours after reperfusion<br>Diagnostic Test: Laboratory values - 7 days after reperfusion<br>* Laboratory values will be obtained 7 days after reperfusion<br>Diagnostic Test: Laboratory values - 90 days after reperfusion<br>* Laboratory values will be obtained 90 days after reperfusion<br>Other: Medical information during organ harvesting/transplantation<br>* Medical information during organ harvesting/transplantation hypotension MAP 65 Torr > 5 minutes (YES/NO) vasopressor support (YES/NO, duration in minutes)<br>Procedure: Organ harvesting<br>* Organ harvesting for transplant<br>|
| Organ recipients<br>Group of organ recipients | Diagnostic Test: Laboratory values - baseline<br>* Baseline laboratory values will be obtained<br>Diagnostic Test: Laboratory values - 12 hours after reperfusion<br>* Laboratory values will be obtained 12 hours after reperfusion<br>Diagnostic Test: Laboratory values - 48 hours after reperfusion<br>* Laboratory values will be obtained 48 hours after reperfusion<br>Diagnostic Test: Laboratory values - 7 days after reperfusion<br>* Laboratory values will be obtained 7 days after reperfusion<br>Diagnostic Test: Laboratory values - 90 days after reperfusion<br>* Laboratory values will be obtained 90 days after reperfusion<br>Other: Medical information during organ harvesting/transplantation<br>* Medical information during organ harvesting/transplantation hypotension MAP 65 Torr > 5 minutes (YES/NO) vasopressor support (YES/NO, duration in minutes)<br>Procedure: Organ transplantation<br>* Transplantation of the harvested organ<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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organ donor, organ recipient, transplant medicine, acute kidney injury