A New HC-A II Solution for Kidney Preservation: A Multi-Center Randomized Controlled Trial in China.
Sui M, Zhang L, et al.Annals of Transplantation 2014; 19: 614-620.
Aims
To study the efficacy and safety of Hypertonic citrate adenine (HC-A) II in kidney preservation.
Interventions
Patients were randomly assigned to receive kidneys flushed and preserved with either HC-A II, or histidine-tryptophan-ketoglutarate solution (HTK) as control.
Participants
277 kidney transplant recipients aged >18 years.
Outcomes
Primary outcomes measured were patient and graft survival, and estimated glomerular filtration rate (eGFR). Safety outcomes measured were vital signs, blood and urine values, liver/kidney function, electrolytes, electrocardiography (ECG) and all adverse events.
Follow-up
28 days
CET Conclusions
This is a multi-centre report of 9 Chinese hospitals comparing a new preservation solution of hypertonic citrate adenine (HC-A II) with HTK. A sample size calculation was done although it was unclear on which outcome it was based. Throughout the manuscript the authors state the recipients were randomised but these must be the donors. The method of double-blinding was not further described although on request the corresponding author confirmed to us that both patients and all medical personnel were blinded. The report includes 277 deceased donors and reports on an equal number of recipients. The 1-month follow-up efficacy data show no differences in patient and graft survival, renal function or delayed graft function. One-month safety data show a lower overall adverse event rate for the HC-A II group. No firm conclusions can be drawn from these early trial results.
Data analysis
Per protocol analysis
Trial registration
None