Balanced crystalloid solution versus saline in deceased donor kidney transplantation (BEST-Fluids): a pragmatic, double-blind, randomised, controlled trial.
Collins, M. G., et al.Lancet 2023; 402(10396): 105-117.
Aims
To assess if use of balanced crystalloid vs saline reduces rates of delayed graft function.
Interventions
The intervention group received a balanced crystalloid in the form of Plasma-Lyte 148 intra- and post-operatively for intravenous volume replacement vs standard care who received 0.9% sodium chloride.
Participants
808 participants, adults and children receiving kidney only transplant.
Outcomes
The primary outcome was DGF, which they defined as need for dialysis within the first 7 days. Secondary outcomes included: number of dialysis treatments, duration of dialysis in days, ranked composite of DGF and day2 creatinine reduction ratio, post-op hyperkalaemia, peak potassium, fluid overload, urine output, use of inotropes, acute rejection, number of biopsies, mortality, graft survival, graft function and hospital stay.
Follow-up
52 weeks
CET Conclusions
This large, multi-centre, double-blinded, randomised control trial found a reduction in DGF rate with the use of balanced crystalloid (30%) compared with normal saline (40%), a RR of 0.74 (p<0.0001). The trial was well designed, with exceptional blinding, the Plasma-Lyte and saline were packaged in custom identical bags only identifiable by serial numbers, so all parties were blinded for the duration of the trial. The trial was conducted across 16 sites, with a representative trial cohort of deceased donor kidneys (DBD:DCD of 3:1), containing only 16 (2%) of pre-emptive recipients and 20 (2%) kidneys that received HMP as preservation, which is crucial given their primary outcome. This reduction in DGF equated to 190 fewer dialysis sessions in the balanced crystalloid group and a number needed to treat of 10 to prevent 1 case of DGF. Their hypothesised effect of the fluid on post-transplant biochemistry, with reduced chloride burden, increase bicarbonate and pH with minimal effect on potassium was demonstrated and thus reduced tubular acidosis and improve blood flow leading to lower rates of DGF is sound. The trial has few limitations, laboratory data wasn’t collected beyond post-operative day 2 and other minor data points such as blood pressure and surgical anastomosis time, however given the trial size and randomisation strategy limiting centre effect, this is likely of no consequence. It is important to note that the effect is not necessarily generalisable to other balanced crystalloids such as Hartman’s, given that contains more chloride as well as lactate and further work would be needed to assess their benefit. This trial provides robust evidence sufficient to warrant consideration of changing practice, Plasma-Lyte is readily available, relatively inexpensive and in the context of renal transplant providing likely reduction in DGF.
Data analysis
Modified intention-to-treat analysis
Trial registration
ACTRN12617000358347; ClinicalTrials.gov - NCT03829488