Acute Kidney InjuryNCT05538234
Biomarkers of Kidney Function in Transplant Medicine
An observational study of Acute Kidney Injury, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Laboratory values - baseline, Medical information 12 hours before organ harvesting and Laboratory values - 12 hours after reperfusion
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Living and deceased organ donors, organ recipients.
Who may be able to join
- 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
Who cannot join
- disapproval of family members with the enrolment of the patient in the study
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Peter Sklienka, MD, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Laboratory values - baseline, Medical information 12 hours before organ harvesting, Laboratory values - 12 hours after reperfusion, Laboratory values - 48 hours after reperfusion, Laboratory values - 7 days after reperfusion
- Keywords
- organ donor, organ recipient, transplant medicine, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory values - baselineDiagnostic test
Baseline laboratory values will be obtained
Medical information 12 hours before organ harvestingOther
- 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 reperfusionDiagnostic test
Laboratory values will be obtained 12 hours after reperfusion
Laboratory values - 48 hours after reperfusionDiagnostic test
Laboratory values will be obtained 48 hours after reperfusion
Laboratory values - 7 days after reperfusionDiagnostic test
Laboratory values will be obtained 7 days after reperfusion
Laboratory values - 90 days after reperfusionDiagnostic test
Laboratory values will be obtained 90 days after reperfusion
Medical information during organ harvesting/transplantationOther
Medical information during organ harvesting/transplantation
- hypotension MAP 65 Torr > 5 minutes (YES/NO)
- vasopressor support (YES/NO, duration in minutes)
Organ harvestingProcedure or surgery
Organ harvesting for transplant
Organ transplantationProcedure or surgery
Transplantation of the harvested organ
| Study group | Role | What they receive |
|---|---|---|
| Non-living organ donors | Group of non-living donors Receives: Diagnostic Test: Laboratory values - baseline; Other: Medical information 12 hours before organ harvesting; Other: Medical information during organ harvesting/transplantation; Procedure: Organ harvesting | |
| Living organ donors | Group of living organ donors Receives: Diagnostic Test: Laboratory values - baseline; 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 | |
| Organ recipients | Group of organ recipients Receives: Diagnostic Test: Laboratory values - baseline; 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 transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of kidney dysfunction biomarkers
Sensitivity of kidney dysfunction biomarkers will be assessed using the Kidney Donor Risk Index and Kidney Donor Profile Index
Measured: up to 90 days after the procedure
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: up to 90 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Sklienka, MD, Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538234
- Sponsor's protocol ID
- KARIM-827/2021
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Kidney Function in Transplant Medicine
- ClinicalTrials.gov ID
- NCT05538234
- Acronym / sponsor ID
- KARIM-827/2021
- Conditions
- Acute Kidney Injury
- Keywords
- organ donor, organ recipient, transplant medicine, acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-living organ donors | – | Diagnostic Test: Laboratory values - baseline, Other: Medical information 12 hours before organ harvesting, Other: Medical information during organ harvesting/transplantation, Procedure: Organ harvestingGroup of non-living donors |
| Living organ donors | – | Diagnostic Test: Laboratory values - baseline, 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 harvestingGroup of living organ donors |
| Organ recipients | – | Diagnostic Test: Laboratory values - baseline, 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 transplantationGroup of organ recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Living and deceased organ donors, organ recipients.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- disapproval of family members with the enrolment of the patient in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory values - baselineBaseline laboratory values will be obtained | Diagnostic test | Living organ donors, Non-living organ donors, Organ recipients |
| 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) | Other | Non-living organ donors |
| Laboratory values - 12 hours after reperfusionLaboratory values will be obtained 12 hours after reperfusion | Diagnostic test | Living organ donors, Organ recipients |
| Laboratory values - 48 hours after reperfusionLaboratory values will be obtained 48 hours after reperfusion | Diagnostic test | Living organ donors, Organ recipients |
| Laboratory values - 7 days after reperfusionLaboratory values will be obtained 7 days after reperfusion | Diagnostic test | Living organ donors, Organ recipients |
| Laboratory values - 90 days after reperfusionLaboratory values will be obtained 90 days after reperfusion | Diagnostic test | Living organ donors, Organ recipients |
| Medical information during organ harvesting/transplantationMedical information during organ harvesting/transplantation * hypotension MAP 65 Torr > 5 minutes (YES/NO) * vasopressor support (YES/NO, duration in minutes) | Other | Living organ donors, Non-living organ donors, Organ recipients |
| Organ harvestingOrgan harvesting for transplant | Procedure or surgery | Living organ donors, Non-living organ donors |
| Organ transplantationTransplantation of the harvested organ | Procedure or surgery | Organ recipients |
Primary outcome
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
4 secondary outcomes
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
Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia
Time frame: during organ harvesting
Predictive value of Acute Kidney Injury biomarkers in organ recipients
Time frame: up to 90 days after transplantation
Association between donor kidney dysfunction with selected risk factors
Time frame: up to 90 days after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No. Individual participant data may be provided upon request.
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Sklienka, MD, Ph.D. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of kidney dysfunction biomarkers (time frame: up to 90 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.