Thoracoabdominal Aortic Aneurysms Clinical Trial
Official title:
CUstodiol Versus RInger: whaT Is the Best Agent? A Randomized Double Blind Trial.
Postoperative renal failure is the most significant risk factor for early mortality after
elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).
To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair,
the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since
the most studied crystalloid solution is the Ringer's lactate solution, this can be
considered the standard of care for evaluating the effectiveness of other substrates.
An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr.
Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during
transplantation and for cardioplegia during open-heart surgery in most EU countries. This
solution may provide a better grade of renal protection to ischemic damage than the standard
crystalloid solutions.
A recent observational study published by our group suggested a lower incidence of
postoperative renal kidney injury in patients undergoing open TAAA surgical repair using
renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's
lactate solution.
Objective of this study is the confirmation of the promising findings about the effectiveness
of renal perfusion with Custodiol during repair of TAAA compared with other crystalloid.
The study will be a prospective, single-center, randomized, double-blind, controlled trial,
investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol
renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult
patients undergoing elective TAAA open repair. Participants will be followed for the duration
of hospital stay, an expected average of 2 weeks.
n/a
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