The applicability of machine perfusion preservation by the Airdrive system in kidney transplantation.
- Conditions
- The patiënts which are to be included in this study have kidney problems which can only be treated by kidney replacement therapy In this pilot we do not study the underlying disease We study the safety of a new machine perfusion system
- Registration Number
- NL-OMON22914
- Lead Sponsor
- Academic Medical Center AmsterdamMeibergdreef 91105 AZAmsterdam
- Brief Summary
Doorschodt B.M., et al., Evaluation of a novel system for hypothermic oxygenated pulsatile perfusion preservation. Int J of Artif Organs 32, 728-38 2009<br> Schreinemachers M.C. et al., Pulsatile perfusion of warm ischaemia damaged experimental kidney grafts. Br. J of Surg 97, 349-358 2010
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 7
Patient has to be at least 18 years of age and mentally competent;
-Voluntary signed and dated Informed Consent Form of the patient has to be obtained prior to any study-specific procedure.
Kidney grafts which are expected to be transplanted within 2 hours after arrival in the AMC, will be excluded to guarantee no extension of cold ischemic times due to Airdrive™ machine perfusion. Estimation of this duration will be done by the transplant surgeon or surgical resident.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The absence of adverse events due to the use of Airdrive oxygenated machine perfusion as preservation method during kidney transplantation.
- Secondary Outcome Measures
Name Time Method Renal function parameters such as serum creatinine and blood urea will be evaluated, as well as histological analyses of a perioperatively harvested graft biopsy.