Andrea Kahlberg, Yamume Tshomba, Domenico Baccellieri, Luca Bertoglio, Enrico Rinaldi, Vincenzo Ardita, Elisa Colombo, Umberto Moscato, Germano Melissano, Roberto Chiesa, Luca Apruzzi, Samuele Bossi, Renata Castellano, Barbara Catenaccio, Angela Maria Ferrante, Giovanni Landoni, Rosalba Lembo, Pasquale Nardelli, Laura Pasin, Elisa Simonini, Massimo Venturini, University of Zurich, Kahlberg, Andrea, Kahlberg, A., Tshomba, Y., Baccellieri, D., Bertoglio, L., Rinaldi, E., Ardita, V., Colombo, E., Moscato, U., Melissano, G., Chiesa, R., Apruzzi, L., Bossi, S., Castellano, R., Catenaccio, B., Ferrante, A. M., Landoni, G., Lembo, R., Nardelli, P., Pasin, L., Simonini, E., and Venturini, M.
Objective The objective of this study was to compare the efficacy of renal perfusion with Custodiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany) versus enriched Ringer's solution for renal protection in patients undergoing open thoracoabdominal aortic aneurysm (TAAA) repair. Methods Ninety consecutive patients scheduled for elective open TAAA repair were enrolled between 2015 and 2017 in a single-center, phase IV, prospective, parallel, randomized, double-blind trial (the CUstodiol versus RInger: whaT Is the Best Agent [CURITIBA] trial), and randomized to renal arteries perfusion with 4°C Custodiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany; n = 45) or 4°C lactated Ringer's solution (n = 45). The incidence of acute kidney injury (AKI) in patients undergoing TAAA open surgery using Custodiol renal perfusion versus an enriched Ringer's solution was the primary end point. Results Ninety patients completed the study (45 patients in each group). The incidence of postoperative AKI was significantly lower in the Custodiol group (48.9% vs 75.6%; P = .02). In the multivariable model, only the use of Custodiol solution resulted as protective from the occurrence of any AKI (odds ratio, 0.230; 95% confidence interval, 0.086-0.614; P = .003), whereas TAAA type II extent was associated with the development of severe AKI (odds ratio, 4.277; 95% confidence interval, 1.239-14.762; P = .02). At 1-year follow-up, serum creatinine was not significantly different from the preoperative values in both groups. Conclusions The use of Custodiol during open TAAA repair was safe and resulted in significantly lower rates of postoperative AKI compared with Ringer's solution. These findings support safety and efficacy of Custodiol in this specific setting, which is currently off-label.