Objective: The objective of this study was to compare the efficacy of renal perfu-sion with Custodiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany) versus enriched Ringer's solution for renal protection in patients undergoing open thora-coabdominal 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, par-allel, randomized, double-blind trial (the CUstodiol versus RInger: whaT Is the Best Agent [CURITIBA] trial), and randomized to renal arteries perfusion with 4 degrees C Cus-todiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany; n = 45) or 4 degrees C lactated Ringer's solution (n = 45). The incidence of acute kidney injury (AKI) in patients un-dergoing 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 inci-dence 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 re-sulted as protective from the occurrence of any AKI (odds ratio, 0.230; 95% con-fidence 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. (J Thorac Cardiovasc Surg 2023;165:569-79)

Kahlberg, A., Tshomba, Y., Baccellieri, D., Bertoglio, L., Rinaldi, E., Ardita, V., Colombo, E., Moscato, U., Melissano, G., Chiesa, R., Renal perfusion with histidine-tryptophan-ketoglutarate compared with Ringer's solution in patients undergoing thoracoabdominal aortic open repair, <<JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY>>, 2023; 165 (2): 569-579.e5. [doi:10.1016/j.jtcvs.2021.02.090] [https://hdl.handle.net/10807/249222]

Renal perfusion with histidine-tryptophan-ketoglutarate compared with Ringer's solution in patients undergoing thoracoabdominal aortic open repair

Tshomba, Yamume;Moscato, Umberto;
2023

Abstract

Objective: The objective of this study was to compare the efficacy of renal perfu-sion with Custodiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany) versus enriched Ringer's solution for renal protection in patients undergoing open thora-coabdominal 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, par-allel, randomized, double-blind trial (the CUstodiol versus RInger: whaT Is the Best Agent [CURITIBA] trial), and randomized to renal arteries perfusion with 4 degrees C Cus-todiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany; n = 45) or 4 degrees C lactated Ringer's solution (n = 45). The incidence of acute kidney injury (AKI) in patients un-dergoing 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 inci-dence 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 re-sulted as protective from the occurrence of any AKI (odds ratio, 0.230; 95% con-fidence 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. (J Thorac Cardiovasc Surg 2023;165:569-79)
2023
Inglese
Kahlberg, A., Tshomba, Y., Baccellieri, D., Bertoglio, L., Rinaldi, E., Ardita, V., Colombo, E., Moscato, U., Melissano, G., Chiesa, R., Renal perfusion with histidine-tryptophan-ketoglutarate compared with Ringer's solution in patients undergoing thoracoabdominal aortic open repair, <<JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY>>, 2023; 165 (2): 569-579.e5. [doi:10.1016/j.jtcvs.2021.02.090] [https://hdl.handle.net/10807/249222]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/249222
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