Biomarkers of Kidney Function in Transplant Medicine
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Diagnostic test: Laboratory values - baseline
- Other: Medical information 12 hours before organ harvesting
- Other: Medical information during organ harvesting/transplantation
- Procedure: 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
- Procedure: Organ transplantation
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
Study Locations
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Czechia, 70852
- Recruiting
- University Hospital Ostrava
-
Contact:
- Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
-
Principal Investigator:
- Peter Sklienka, MD, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-living organ donors
Group of non-living donors
|
Baseline laboratory values will be obtained
Medical information during organ harvesting/transplantation
Organ harvesting for transplant
|
|
Living organ donors
Group of living organ donors
|
Baseline laboratory values will be obtained
Medical information during organ harvesting/transplantation
Organ harvesting for transplant
Laboratory values will be obtained 12 hours after reperfusion
Laboratory values will be obtained 48 hours after reperfusion
Laboratory values will be obtained 7 days after reperfusion
Laboratory values will be obtained 90 days after reperfusion
|
|
Organ recipients
Group of organ recipients
|
Baseline laboratory values will be obtained
Medical information during organ harvesting/transplantation
Laboratory values will be obtained 12 hours after reperfusion
Laboratory values will be obtained 48 hours after reperfusion
Laboratory values will be obtained 7 days after reperfusion
Laboratory values will be obtained 90 days after reperfusion
Transplantation of the harvested organ
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of kidney dysfunction biomarkers
Time Frame: 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
|
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
Time Frame: 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.
|
during baseline data collection
|
|
Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia
Time Frame: during organ harvesting
|
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
Time Frame: 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
|
up to 90 days after transplantation
|
|
Association between donor kidney dysfunction with selected risk factors
Time Frame: up to 90 days after transplantation
|
Association between donor kidney dysfunction with selected risk factors will be assessed (ion disbalance, circulatory instability)
|
up to 90 days after transplantation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Sklienka, MD, Ph.D., University Hospital Ostrava
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KARIM-827/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.