title: Remote ischaemic conditioning on recipients of deceased renal transplants, effect on immediate and extended kidney graft function: a multicentre, randomised controlled trial protocol (CONTEXT).
abstract: BACKGROUND
  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
  '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.
  
  
  BACKGROUND
  The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2016.
  
  
  BACKGROUND
  NCT01395719.
authors: Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.
authors: Nicoline V
authors: NV
authors: Krogstrup
authors: The Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Mihai
authors: M
authors: Oltean
authors: Department of Biostatistics, Aarhus, Denmark.
authors: Bo M
authors: BM
authors: Bibby
authors: Department of Anaesthesiology, University Medical Center Groningen, Groningen, The Netherlands.
authors: Gertrude J
authors: GJ
authors: Nieuwenhuijs-Moeke
authors: Division of HPB & Transplant Surgery, Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors: Frank J M F
authors: FJ
authors: Dor
authors: Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark Department of Biomedicine, Aarhus University, Aarhus, Denmark.
authors: Henrik
authors: H
authors: Birn
authors: Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.
authors: Bente
authors: B
authors: Jespersen
mesh_terms: D000293:Adolescent; D000328:Adult; D000771:Anesthesia, Intravenous; D004992:Ethics, Medical; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D019194:Ischemic Preconditioning / Q000379:methods*; D016030:Kidney Transplantation; D015427:Reperfusion Injury / Q000517:prevention & control*; D013848:Thigh / Q000098:blood supply; D014019:Tissue Donors; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents
keywords: delayed graft function; glomerular filtration rate; ischaemia reperfusion injury; remote ischemic conditioning