CUstodiol Versus RInger: whaT Is the Best Agent?

Scientific Institute San Raffaele

Status and phase: Completed; Phase 4

Conditions: Thoracoabdominal Aortic Aneurysms

Treatments: Drug: Custodiol; Drug: Enriched Ringer's lactate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02327611

CURITIBA/9/OSR

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Ability to provide written informed consent; Patient undergoing open surgical repair of TAAA requiring renal perfusion.

Exclusion criteria

1. Patients who have participated to experimental trials during the previous 3 months
2. Intervention under emergency / urgency
3. Patient uncooperative and / or affected by mental disease
4. Allergy or intolerance to the study drug
5. Patient under renal replacement treatment (dialysis) before surgery
6. Pregnant or breast-feeding women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Custodiol

Experimental group

Description:

Renal perfusion with Custodiol (cold crystalloid solution enriched with histidine-tryptophan-ketoglutarate).

Treatment:

Drug: Custodiol

enriched Ringer's lactate solution

Active Comparator group

Description:

Renal perfusion with cold Ringer's lactate solution enriched with methylprednisolone 125 mg /L and mannitol 12.5 g /L.

Treatment:

Drug: Enriched Ringer's lactate solution