Volatile Anesthetic Protection of Renal transplants-2 - VAPOR-2

ClinicalTrials.gov: NCT02727296 Research
ClinicalTrials.gov: NCT02727296
A European multicentre trial to study the effects of 2 commonly used anaesthetic agents in recipients on graft and patient outcome in kidney transplantation with kidneys from deceased donors.

Ischemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively impacts graft and patient outcome. Since reperfusion takes place in the recipient and most of the injury following ischemia and reperfusion occurs during this reperfusion phase, the intra-operative period seems an attractive window of opportunity to modulate IRI and improve short and potentially long term graft outcome. Commonly used volatile anaesthetics like sevoflurane and isoflurane have shown to interfere with many of the pathophysiological processes involved in the injurious cascade of IRI.

Our objective is to compare the effect of a sevoflurane based anaesthesia versus a propofol based anaesthesia on the incidence of delayed graft function in recipients of DCD (Deceased Circulatory Death) and DBD (Deceased Brain Death) donor kidneys.


ClinicalTrials.gov: NCT02727296

Relevance

How our research benefits to society

To date, 10% of the worldwide population suffers from chronic kidney disease (CKD). Prevalence of the disease will most likely grow over the next decade due to increase of the elderly population and growing incidence of diabetes and hypertension. In 2015 CKD was ranked 12th in the global list of causes of death and projection is that by 2040 CKD will be the 5th leading cause of morality.

  • For patients with end stage renal disease (ESRD) transplantation is still the optimal treatment. Long term survival after kidney transplantation is dramatically better than dialysis and transplantation provides a sustainably higher quality of life. If successful, transplantation is more cost effective compared with long-term dialysis treatment in patients of all ages.

    Suitable donor organs for transplantation

    Unfortunately, there is a worldwide shortage of suitable donor organs for (kidney) transplantation which forces transplant teams to extend the donor criteria and to accept more older and higher risk organs retrieved from deceased donors. The use of these extended criteria donors has affected outcomes after transplantation due to an often suboptimal quality of the donor organ. As we will face more complex donors in the future with a reduced viability, the challenge in transplantation is to be able to use these donor sources, however, without compromising successful immediate function and long-term graft survival after transplantation. It is therefore imperative that the condition of every graft-to-be is optimised prior to or at the time of transplantation and that additional injury is minimised in order to achieve the best possible post-transplant function and avoid primary non function (PNF), delayed graft function (DGF), and rejection with chronic graft failure.

  • Ischemia and reperfusion injury (IRI) is inevitable in (kidney) transplantation and one of the most important underlying mechanisms for PNF or DGF. Volatile anesthetic agents interfere with many of the processes underlying the pathophysiology of IRI encountered in kidney transplantation. Its use in kidney transplant recipients therefore could have a protective effect against the consequences of IRI and improves graft and patient outcome.

  • With VAPOR-2 we aim to identify the ideal anaesthetic agent used during the transplantation procedure and elucidate involved pathways of protection. In addition we want to raise awareness for this perioperative period as an important window of opportunity to modulate or reduce renal injury in kidney transplantation.

  • The UMCG is the academic lead partner in this European multicenter project in which currently 5 academic centers are involved. Our partners are: Aarhus University Hospital (Denmark), Fundiagio Puigvert (Barcelona, Spain), Oslo University Hopsital (Norway) and Amsterdam University Medical Center (the Netherlands)

    Our teams are based in:

    • Groningen 
    • Barcelona
    • Aarhus
    • Oslo
    • Amsterdam
  • The VAPOR-2 study is funded by:

    • The Astellas European Foundation Transplantation Grant 2014
    • The ESA grant supported by an unrestricted research grant from Baxter -2017
  • Excecution links for participating centers:

    Randomization
    eCRF

Contact

Gertrude Nieuwenhuijs-Moeke
Gertrude Nieuwenhuijs-Moeke Assistant Professor of Anesthesiology, Peri-operative pharmacology, organ protection and inflammation, Principal Investigator