CUstodiol Versus RInger: whaT Is the Best Agent?

Thoracoabdominal Aortic Aneurysms Clinical Trial

Official title:

CUstodiol Versus RInger: whaT Is the Best Agent? A Randomized Double Blind Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327611
• Other study ID #: CURITIBA/9/OSR
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: January 17, 2018

Study information

• Verified date: May 2019
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 17, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracoabdominal Aortic Aneurysms

Intervention

Drug:
• Custodiol

• Enriched Ringer's lactate solution

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury		Kidney function will be assessed during hospital stay (an expected average of 2 weeks)