CUstodiol Versus RInger: whaT Is the Best Agent?
|ClinicalTrials.gov Identifier: NCT02327611|
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : May 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Thoracoabdominal Aortic Aneurysms||Drug: Custodiol Drug: Enriched Ringer's lactate solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CUstodiol Versus RInger: whaT Is the Best Agent? A Randomized Double Blind Trial.|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||January 17, 2018|
|Actual Study Completion Date :||January 17, 2018|
Renal perfusion with Custodiol (cold crystalloid solution enriched with histidine-tryptophan-ketoglutarate).
Active Comparator: enriched Ringer's lactate solution
Renal perfusion with cold Ringer's lactate solution enriched with methylprednisolone 125 mg /L and mannitol 12.5 g /L.
Drug: Enriched Ringer's lactate solution
- Acute Kidney Injury [ Time Frame: Kidney function will be assessed during hospital stay (an expected average of 2 weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327611
|San Raffaele Hospital|
|Milano, Italy, 20132|