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Medical Science Monitor Basic Research


eISSN: 2329-0358

A New HC-A II Solution for Kidney Preservation: A Multi-Center Randomized Controlled Trial in China

Mingxing Sui, Lei Zhang, Jinghui Yang, Li Zeng, Wenyu Zhao, Youhua Zhu

Organ Transplantation Institute of PLA, Changzheng Hospital, Second Military Medical University, Shanghai, China (mainland)

Ann Transplant 2014; 19:614-620

DOI: 10.12659/AOT.892250

Available online: 2014-11-27

Published: 2014-11-27

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 and 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.

Keywords: Kidney Transplantation, Organ Preservation, Organ Preservation Solutions, Randomized controlled trial