ormothermic Machine perfusion: an additional value for kidney transplant outcomes?

Phase 2

Recruiting

• Conditions: Kidney transplantation; postmortal kidney transplantation; 10038430; 10038365

• Registration Number: NL-OMON54462
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Kidney related:
In order to be eligible to participate in this study, the donor kidney must
meet the following criteria:
- Donation after Circulatory Death (DCD) type III/IV/V (Maastricht criteria) OR
- Donation after Brain Death (DBD) donor kidney IF the kidney meets ECD
criteria:
o Donor >=60, OR
o Donor 50-59 years with 2 of the following risk factors: history of high blood
pressure, creatinine greater than or equal to 1.5 mg/dl (133 umol/l), death
resulting from stroke.

Recipient related:
- Adult (>=18 years old) recipients.
- Mentally competent recipients.
- Recipients who receive renal replacement therapy at the moment of
transplantation.
- Recipients who provided written informed consent.

Exclusion Criteria

- Multi-organ transplant recipients (such as combined liver/kidney).
- Receiving a donor kidney preserved on static cold storage.
- Receiving a donor kidney that is explanted after normothermic regional
perfusion.
- DCD type I and II (Maastricht criteria).
- Dual kidney transplantation
- The patient receives another immunosuppression regime than standard-of-care
(which is induction with basiliximab followed by triple therapy with
tacrolimus, mycofenolate mofetil and prednisone)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of DGF/PNF.</p><br>