Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2023-01-01
2026-03-31
Brief Summary
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The project is aimed at monitoring biomarkers of acute kidney dysfunction in deceased organ donors, living organ donors, and organ recipients.
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Non-living organ donors
Group of non-living donors
Laboratory values - baseline
Baseline laboratory values will be obtained
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)
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)
Organ harvesting
Organ harvesting for transplant
Living organ donors
Group of living organ donors
Laboratory values - baseline
Baseline laboratory values will be obtained
Laboratory values - 12 hours after reperfusion
Laboratory values will be obtained 12 hours after reperfusion
Laboratory values - 48 hours after reperfusion
Laboratory values will be obtained 48 hours after reperfusion
Laboratory values - 7 days after reperfusion
Laboratory values will be obtained 7 days after reperfusion
Laboratory values - 90 days after reperfusion
Laboratory values will be obtained 90 days after reperfusion
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)
Organ harvesting
Organ harvesting for transplant
Organ recipients
Group of organ recipients
Laboratory values - baseline
Baseline laboratory values will be obtained
Laboratory values - 12 hours after reperfusion
Laboratory values will be obtained 12 hours after reperfusion
Laboratory values - 48 hours after reperfusion
Laboratory values will be obtained 48 hours after reperfusion
Laboratory values - 7 days after reperfusion
Laboratory values will be obtained 7 days after reperfusion
Laboratory values - 90 days after reperfusion
Laboratory values will be obtained 90 days after reperfusion
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)
Organ transplantation
Transplantation of the harvested organ
Interventions
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Laboratory values - baseline
Baseline laboratory values will be obtained
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)
Laboratory values - 12 hours after reperfusion
Laboratory values will be obtained 12 hours after reperfusion
Laboratory values - 48 hours after reperfusion
Laboratory values will be obtained 48 hours after reperfusion
Laboratory values - 7 days after reperfusion
Laboratory values will be obtained 7 days after reperfusion
Laboratory values - 90 days after reperfusion
Laboratory values will be obtained 90 days after reperfusion
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)
Organ harvesting
Organ harvesting for transplant
Organ transplantation
Transplantation of the harvested organ
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Peter Sklienka, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KARIM-827/2021
Identifier Type: -
Identifier Source: org_study_id
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