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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custodiol | Experimental | Renal perfusion with Custodiol (cold crystalloid solution enriched with histidine-tryptophan-ketoglutarate). |
|
| enriched Ringer's lactate solution | Active Comparator | Renal perfusion with cold Ringer's lactate solution enriched with methylprednisolone 125 mg /L and mannitol 12.5 g /L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custodiol | Drug |
| ||
| Enriched Ringer's lactate solution |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury | Kidney function will be assessed during hospital stay (an expected average of 2 weeks) |
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Inclusion Criteria:
Ability to provide written informed consent; Patient undergoing open surgical repair of TAAA requiring renal perfusion.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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|
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |