Biomarkers of Kidney Function in Transplant Medicine

Acute Kidney Injury Clinical Trial

Official title:

Biomarkers of Kidney Function in Transplant Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538234
• Other study ID #: KARIM-827/2021
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: September 2023
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• Laboratory values - baseline
Baseline laboratory values will be obtained

Other:
• 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)

Diagnostic Test:
• 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

Other:
• 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)

Procedure:
• Organ harvesting
Organ harvesting for transplant
• Organ transplantation
Transplantation of the harvested organ

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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