No registrations found.
ID
Source
Health condition
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
Sponsors and support
Meibergdreef 9
1105 AZ
Amsterdam
Meibergdreef 9
1105 AZ
Amsterdam
Intervention
Outcome measures
Primary outcome
The absence of adverse events due to the use of Airdrive oxygenated machine perfusion as preservation method during kidney transplantation.
Secondary outcome
Renal function parameters such as serum creatinine and blood urea will be evaluated, as well as histological analyses of a perioperatively harvested graft biopsy.
Background summary
Kidney donor graft shortage for transplantation has led to the use of marginal donors such as non-heart beating donor (NHBD) kidneys. As perfusion in this category of donor patients is absent prior to graft nephrectomy, NHBD kidneys suffer warm ischemia, causing damage, which is associated with early and late graft loss. Preservation of the graft by hypothermic machine perfusion instead of conventional cold static storage provides a viable solution to reduce the warm ischemic damage-induced graft loss. In preclinical animal studies, the Airdrive™ machine perfusion system has shown to be safe, and to improve renal function and graft structural integrity after induced warm ischemic damage. The next step is to introduce the Airdrive™ system in a clinical setting. To this end, a pilot-study using the Airdrive™ system for the preservation of kidney grafts was devised to demonstrate that the machine perfusion system is ‘safe’ for use in the clinical setting. In this pilot-study we hypothesize that the use of the Airdrive™ machine perfusion system is safe and technically feasible for graft preservation in kidney transplantation.
Study objective
It is safe to use the Airdrive machine perfusion system as a preservation method in kidney transplantation.
Study design
Renal function parameters will be routinely checked and are all part of the standard patient care protocol of the AMC hospital.
Intervention
All seven kidney grafts will be preserved using the Airdrive machine perfusion system between arrival at the AMC and implantation in the recipient instead of continuation of conventional cold storage.
P.O. Box 226600
Meibergdreef 9
T.M. Gulik, van
Amsterdam 1100 DD
The Netherlands
Tel +31 20 56 65570
P.O. Box 226600
Meibergdreef 9
T.M. Gulik, van
Amsterdam 1100 DD
The Netherlands
Tel +31 20 56 65570
Inclusion criteria
- 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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5695 |
NTR-old | NTR5847 |
CCMO | NL52704.018.15 |
OMON | NL-OMON42777 |
Summary results
Schreinemachers M.C. et al., Pulsatile perfusion of warm ischaemia damaged experimental kidney grafts. Br. J of Surg 97, 349-358 2010