Remote ischaemic conditioning and early changes in plasma creatinine as markers of one year kidney graft function-A follow-up of the CONTEXT study.
Nielsen, M. B. et al.PLoS ONE [Electronic Resource] 2019; 14(12): e0226882.
Aims
This follow-up of the CONTEXT study aimed to assess the results of remote ischaemic conditioning (RIC) on one-year kidney allograft outcomes, and to determine whether the estimated time to a 50% reduction in plasma creatinine post-transplantation (tCr50) is able to predict the glomerular filtration rate (GFR) at 12 months.
Interventions
Patients were randomly assigned to either the RIC group or the sham-RIC group during surgery.
Participants
225 patients undergoing deceased donor kidney transplantation were included.
Outcomes
The outcomes of interest of this study included kidney graft function, rate of rejection, NGAL (neutrophil gelatinase associated lipocalin, NODAT (new onset diabetes after transplantation), patient survival at 3 and 12 months post-transplantation.In addition, GFR was assessed (measured and estimated GFR)
Follow-up
1 year
CET Conclusions
This paper reports one-year outcomes from the multicentre CONTEXT study of Remote Ischaemic Conditioning (RIC) during deceased donor renal transplantation. As this study has been written up now in several reports, this one does not include all the methodological description, however this is easily found. This is a good quality, randomised, and double-blinded controlled trial, with objective outcomes. 225 patients were randomised (90% DBD and 10% DCD). Three patients were withdrawn at the time of surgery due to transplant not going ahead, missing consent and machine malfunction. This study shows that RIC had no impact on DGF rates, 3-month and 12-month measured GFR, which were all similar comparing the 2 study arms, as were graft loss and rejection. This suggests that RIC of the recipient does not confer either short term or long term protection in deceased donor renal transplantation.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT01395719