Biomarkers of Kidney Function in Transplant Medicine

NCT05538234 | Recruiting

• 1 other identifier: KARIM-827/2021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Keywords

organ donor; organ recipient; transplant medicine; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparison of levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death

  during baseline data collection

• Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia

  during organ harvesting

• Predictive value of Acute Kidney Injury biomarkers in organ recipients

  up to 90 days after transplantation

• Association between donor kidney dysfunction with selected risk factors

  up to 90 days after transplantation

Study Arms (3)

Non-living organ donors

Group of non-living donors

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

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

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

Interventions

Laboratory values - baseline DIAGNOSTIC_TEST

Baseline laboratory values will be obtained

Living organ donors; Non-living organ donors; Organ recipients

Medical information 12 hours before organ harvesting OTHER

* 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)

Non-living organ donors

Laboratory values - 12 hours after reperfusion DIAGNOSTIC_TEST

Laboratory values will be obtained 12 hours after reperfusion

Living organ donors; Organ recipients

Laboratory values - 48 hours after reperfusion DIAGNOSTIC_TEST

Laboratory values will be obtained 48 hours after reperfusion

Living organ donors; Organ recipients

Laboratory values - 7 days after reperfusion DIAGNOSTIC_TEST

Laboratory values will be obtained 7 days after reperfusion

Living organ donors; Organ recipients

Laboratory values - 90 days after reperfusion DIAGNOSTIC_TEST

Laboratory values will be obtained 90 days after reperfusion

Living organ donors; Organ recipients

Medical information during organ harvesting/transplantation OTHER

Medical information during organ harvesting/transplantation * hypotension MAP 65 Torr \> 5 minutes (YES/NO) * vasopressor support (YES/NO, duration in minutes)

Living organ donors; Non-living organ donors; Organ recipients

Organ harvesting PROCEDURE

Organ harvesting for transplant

Living organ donors; Non-living organ donors

Organ transplantation PROCEDURE

Transplantation of the harvested organ

Organ recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Living and deceased organ donors, organ recipients.

You may qualify if:

• 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

You may not qualify if:

• \- disapproval of family members with the enrolment of the patient in the study

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected from the study participants.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Transplantation; Tissue and Organ Harvesting; Organ Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Peter Sklienka, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)