Review of randomized clinical trials of donor management and organ preservation in deceased donors: opportunities and issues.

Given the static number of deceased donors, improvements in donor management and organ preservation to increase the number and quality of organs transplanted per donor are more pressing. Because controlled trials provide the best evidence, we conducted a review of English-language literature of trials in donor management and organ preservation to provide a compendium and to promote additional discussion and studies. Eighty-seven reports were retrieved: 13 on hemodynamic and fluid management, 7 on immunosuppressants, 12 on preconditioning, 34 on preservation fluids, and 21 on pulsatile perfusion. Sixteen studies are ongoing. Although hormonal therapy is used widely, additional studies are needed to determine the benefit of thyroid hormone and insulin replacement and to optimize steroid regimens. Dopamine's success in reducing kidney delayed graft function highlights the opportunity for additional preconditioning trials of remote ischemia, gases, opioids, and others. More rapid progress requires addressing unique barriers in consent and research approval, legal constraints precluding research in cardiac death donors, and streamlining collaboration of multiple stakeholders. With little interest from industry, federal funding needs to be increased. While the University of Wisconsin solution still reigns supreme, several promising preservative solutions and additives with not only biophysical but also pharmacological effects are on the cusp of phase 1 to 2 trials. After nearly three decades of uncertainty, the recent success of a European trial has reenergized the topic not only of machine preservation of the kidney but also of other organs evident by trials in progress. However, the costs of such technical innovations merit the burden of rigorous proof from controlled trials.