P-NGAL Day 1 predicts early but not one year graft function following deceased donor kidney transplantation – The CONTEXT study.
Nielsen, M. B., Krogstrup, N. V. et al. (2019).PLoS ONE [Electronic Resource] 14(2): e0212676.
Aims
This study aimed to evaluate the levels and changes in: U- and P-NGAL, U-L-FABP, U-cystatin C, and U-YKL-40 following deceased donor kidney transplantation and to correlate these biomarkers with DGF, early graft function, including measured GFR and estimated GFR.
Interventions
This is a sub study of the CONTEXT trial, which explored the effect of remote ischaemic conditioning on renal transplantation.
Participants
225 patients undergoing deceased donor kidney transplantation from the CONTEXT trial.
Outcomes
Outcomes were assessed as reperfusion time, levels of U- and P-NGAL, U-L-FABP, U-cystatin C, and U-YKL-40, urine output and graft function.
Follow-up
1 year.
CET Conclusions
This paper reports one year follow up from a previously reported, good quality study. The results are from the large, multicentre CONTEXT trial. The prediction of DGF early on may help to optimise clinical management of the patient, and therefore biomarkers to pre-empt this outcome are eagerly sought. In this study several potential biomarkers were assessed and analysed for relationships with clinical outcomes. Whilst plasma NGAL on day 1 after transplantation was associated with DGF, it was less predictive than urine output and did not correlate with 12-month measured GFR. The level of plasma NGAL was related to the dialysis status of the patient pre-operatively, being higher in those on dialysis than pre-dialysis, and this needs to be taken into account. Also, 40% of dialysis patients had DGF, but only 5% of pre-dialysis patients. The paper describes a multivariate analysis but it is not explicitly declared that this important confounder was dealt with. 200 of the patients received DBD kidneys and only 22 DCD, which raises the question of how the biomarker may relate to outcomes of DCD kidneys, which were under-represented in this study and which may have a different mechanism of DGF compared to DBD. None of the biomarkers assessed in this study correlated well with graft function at 3 and 12 months.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT01395719