The effect of modified versus conventional ERAS on clinical and graft outcomes in kidney transplant recipients: A randomised controlled trial

Justification for the study**:**

1.   Kidney transplantation (KT) is best form of renal replacement therapy that gives best quality of life and survival benefits when compared to dialysis in patients with end stage renal disease (ESRD).

2.   The enhanced recovery after surgery pathways is used to optimise perioperative treatment and improve outcomes. It seeks to reduce post-operative opioids intake and reduce length of stay (LOS). ERAS is relatively not a new concept and has been widely used to improve perioperative care in multiple different surgeries. The economic impact of reduced LOS due to applied ERAS protocols has been highlighted in colorectal surgeries.

3.   There is a limited data on ERAS in KT patients. The ERAS in liver transplants showed shorter LOS and significant reduction in hospital costs. The perioperative cost of KT constituted about a third of the first year’s costs. Therefore, an intervention to reduce cost without affecting clinical and graft outcome is warranted.

4.   The majority of studies on ERAS involving transplant recipients were retrospective case series, prospective cohorts with historical cohorts. All concluded that the ERAS is feasible in KT recipients. There were no reports of severe peri-operative complications, readmission rates, or graft failure due to early discharge or community-based peri-operative management.

5.   Following the success of feasibility trials in 2016, researchers are now focussed on pain control with non-opioids such as, pregabalin and ketorolac. All this is aimed improve patient experience and LOS. However, none of the studies have focussed on improving graft function or integrating graft function within the ERAS protocol. Additionally, statistics on complete cost analysis and re-admission rates (conditions needing intervention such as renal artery stenosis, post-operative collection, and urological complications) are lacking.

6.   Based on our findings, the ERAS approach is applicable, and KT recipients can be safely discharged after post-transplant day 5 provided there is no indication for parenteral treatment. However, in the absence complete cost-analysis it appears that many surgeons in the developed countries used the ERAS protocol and began transitioning recipients from in-hospital to community based post-operative care (from day 4 or 5 onwards), and projected cost-saving due to reduced LOS. In view of inadequate graft recovery and possibility of delayed complications that might appear gradually, patients were advised to stay near the hospital and be in close contact with a nephrologist for dialysis and periodic check-up for regular evaluation. Unlike in the developed countries, health insurance companies in India would welcome early discharge protocols but will not extend their coverage for community based post-operative management (that is community accommodation will not be covered by health insurance). Also, an early discharge does not preclude the need for close infection surveillance within the recipients’ community. Furthermore, due to considerable variability of CNI metabolisers in India, at least two trough levels (post-operative day 1 and 4) would be required to achieve an adequate drug level prior to discharge.

7.   Secondly, there is no study in the English literature that compares the two-treatment protocol [modified ERAS versus Conventional ERAS] in patients undergoing KT surgery. However, there are a few articles published in medical journals that are either retrospective case series or prospective observational study with historical cohorts. Ahmed Halawa et al. (2018) included live and deceased donor transplants and compared them to historical cohorts. [1] Although they concluded that the ERAS benefitted both living and deceased donor transplant recipients and reduced LOS, the protocol was not followed by everyone, the groups were heterogeneous, satisfactory score was not calculated for all, and comprehensive cost analysis was never performed. On the contrary, we believe that failure in ERAS group is mostly connected to graft function recovery rather than clinical recovery alone, and LOS among live donor transplants is determined by polyuria, graft recovery and CNI trough levels.

8.   Lastly, a study comparing the ERAS to historical cohorts (prior to 2010) means the two groups differ in many ways including immunosuppressive regimen and surgical procedure, and their results are not completely reflective.

 Reference:

1.   Halawa, A, Rowe, S, Roberts, F, et al. A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program after Renal Transplant Surgery. Exp. Clin. Transplant. 2018, 16, 127–132