Abstract:
INTRODUCTION:Delayed graft function due to ischaemia-reperfusion injury is a frequent complication in deceased donor renal transplantation. Experimental evidence indicates that remote ischaemic conditioning (RIC) provides systemic protection against ischaemia-reperfusion injury in various tissues. METHODS AND ANALYSIS:'Remote ischaemic conditioning in renal transplantation--effect on immediate and extended kidney graft function' (the CONTEXT study) is an investigator initiated, multicentre, randomised controlled trial investigating whether RIC of the leg of the recipient improves short and long-term graft function following deceased donor kidney transplantation. The study will include 200 kidney transplant recipients of organ donation after brain death and 20 kidney transplant recipients of organ donation after circulatory death. Participants are randomised in a 1:1 design to RIC or sham-RIC (control). RIC consists of four cycles of 5 min occlusion of the thigh by a tourniquet inflated to 250 mm Hg, separated by 5 min of deflation. Primary end point is the time to a 50% reduction from the baseline plasma creatinine, estimated from the changes of plasma creatinine values 30 days post-transplant or 30 days after the last performed dialysis post-transplant. Secondary end points are: need of dialysis post-transplant, measured and estimated-glomerular filtration rate (GFR) at 3 and 12 months after transplantation, patient and renal graft survival, number of rejection episodes in the first year, and changes in biomarkers of acute kidney injury and inflammation in plasma, urine and graft tissue. ETHICS AND DISSEMINATION:The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2016. TRIAL REGISTRATION NUMBER:NCT01395719.
journal_name
BMJ Openjournal_title
BMJ openauthors
Krogstrup NV,Oltean M,Bibby BM,Nieuwenhuijs-Moeke GJ,Dor FJ,Birn H,Jespersen Bdoi
10.1136/bmjopen-2015-007941subject
Has Abstractpub_date
2015-08-20 00:00:00pages
e007941issue
8issn
2044-6055pii
bmjopen-2015-007941journal_volume
5pub_type
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