BACKGROUND:Hypertonic citrate adenine (HC-A) solution, containing citrate and adenine, has become the most widely used preservation solution in isolated kidney preservation in China. More than 30 years of clinical application has demonstrated that HC-A is safe and effective. With higher requirement for kidney preservation and less tolerance of preservation-related graft dysfunction, a new solution, HC-A II, for kidney preservation was developed by Shanghai Changzheng Hospital. MATERIAL/ METHODS: Upon approval from the State Food and Drug Administration of China (SFDA), a multi-center randomized controlled trial was performed to study the efficacy and safety of HC-A II in kidney preservation from 2008 to 2012, using histidine-tryptophan-ketoglutarate solution (HTK) as control (HC-A, n=137, and HTK, n=140). There were no differences with regard to donor and recipient demographics or cold ischemia. RESULTS: The trial results showed no significant difference in DGF rate, or patient or graft survival between the 2 groups. No significant difference between the 2 groups was found in the percentage of patients whose serum creatinine (SCr) test results returned to normal within 28 days (P>0.05), nor were there a significant difference in safety evaluation (P>0.05). CONCLUSIONS:HC-A II and HTK appear to have similar efficacy in isolated kidney preservation.
RCT Entities:
BACKGROUND: Hypertonic citrate adenine (HC-A) solution, containing citrate and adenine, has become the most widely used preservation solution in isolated kidney preservation in China. More than 30 years of clinical application has demonstrated that HC-A is safe and effective. With higher requirement for kidney preservation and less tolerance of preservation-related graft dysfunction, a new solution, HC-A II, for kidney preservation was developed by Shanghai Changzheng Hospital. MATERIAL/ METHODS: Upon approval from the State Food and Drug Administration of China (SFDA), a multi-center randomized controlled trial was performed to study the efficacy and safety of HC-A II in kidney preservation from 2008 to 2012, using histidine-tryptophan-ketoglutarate solution (HTK) as control (HC-A, n=137, and HTK, n=140). There were no differences with regard to donor and recipient demographics or cold ischemia. RESULTS: The trial results showed no significant difference in DGF rate, or patient or graft survival between the 2 groups. No significant difference between the 2 groups was found in the percentage of patients whose serum creatinine (SCr) test results returned to normal within 28 days (P>0.05), nor were there a significant difference in safety evaluation (P>0.05). CONCLUSIONS:HC-A II and HTK appear to have similar efficacy in isolated kidney preservation.